A new rapid expert consultation from a standing committee of the National Academies of Sciences, Engineering, and Medicine responds to questions from the White House Office of Science and Technology Policy (OSTP) regarding survival of the COVID-19 virus in relation to temperature and humidity and potential for seasonal reduction and resurgence of cases.

As a novel coronavirus spreads throughout the world and the number of cases and deaths continues to rise, almost no country or community remains untouched by this rapidly evolving threat.

A new rapid expert consultation from a standing committee of the National Academies of Sciences, Engineering, and Medicine.

A new rapid expert consultation from a standing committee of the National Academies of Sciences, Engineering, and Medicine responds to questions from the White House Office of Science and Technology Policy (OSTP) regarding the effectiveness of homemade fabric masks to protect others from the viral spread of COVID-19 from potentially contagious asymptomatic or presymptomatic individuals.

It is critical for the U.S. to continue its funding for the World Health Organization in the midst of the COVID-19 pandemic given the WHO’s lead role in coordinating an international response, especially in developing countries.

At colleges and universities around the nation, scientists and graduate students are seeking out ways to bring their knowledge, skills, and resources to bear in the struggle against COVID-19.

Researchers are scrambling to find effective treatments for COVID-19, which has infected more than 1 million people around the word.

Anthony Fauci and other panelists explored the status of the pandemic, research underway, and the key role of vaccines in bringing the pandemic to an end.

The National Academies of Sciences, Engineering, and Medicine and the National Science Foundation announced today the formation of a Societal Experts Action Network (SEAN) to connect social and behavioral science researchers with decision-makers who are leading the response to COVID-19. SEAN will respond to the most pressing social, behavioral, and economic questions that are being asked by federal, state, and local officials by working with appropriate experts to quickly provide actionable answers.

When it comes to COVID-19 testing, questions remain about which of the tests available are reliable, how much testing is needed, and how to ensure access to testing. The latest COVID-19 Conversations webinar explored the challenges ahead.

The 1.3 million nursing home residents in the U.S. make up less than 0.5 percent of the nation’s population, but represent approximately 15 percent of COVID-19 related deaths to date.

The novel coronavirus has been called “the great equalizer,” when in reality, it has only exacerbated health inequities that racial and ethnic minorities have experienced for decades.

Rubber stoppers are placed onto filled vials of the investigational drug remdesivir at a Gilead manufacturing site in the United States.; Credit: /AP

Updated at 4:59 p.m. ET

The Food and Drug Administration has given emergency use authorization to the antiviral drug remdesivir to treat hospitalized patients with the coronavirus, President Trump on Friday told reporters at the White House.

Gilead CEO Daniel O'Day said remdesivir maker Gilead Sciences is donating 1.5 million vials of the drug and will work with the federal government to distribute it to patients in need.

The news comes days after preliminary results from a study of the drug showed it can help patients recover faster. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, hailed the findings earlier this week as "quite good news."

The authorization means remdesivir can be distributed in the U.S. and given intravenously to treat COVID-19 patients — both adults and children — who are hospitalized with severe disease, the FDA says. The agency defines that category as "patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator."

Discussing the findings about the drug's ability to help COVID-19 patients, O'Day cautioned earlier Friday that remdesivir is used to treat advanced cases, in which people are already hospitalized. The recent positive findings, he said, are a starting point in the fight against the respiratory disease.

"We want to continue to see how we can expand remdesivir to more patient populations," O'Day said on NBC's Today show. "Clearly with other medicines and vaccines to come, this is part, I think — the beginning of our ability to make an impact on this devastating virus."

This content is from Southern California Public Radio. View the original story at SCPR.org.

Opera singer Plácido Domingo, shown here speaking in Spain last July, said earlier this month that he tested positive for the coronavirus.; Credit: Ricardo Rubio/Europa Press via Getty Images

Plácido Domingo has been hospitalized because of COVID-19-related complications, according to multiple reports.

He is in stable condition in an Acapulco, Mexico, hospital and will receive medical attention for "as long as the doctors find it necessary until a hoped-for full recovery," a spokesperson for Domingo told Opera News over the weekend.

Domingo's reported hospitalization comes just days after he posted a March 22 message on Facebook revealing that he had tested positive for the disease caused by the coronavirus.

"I feel it is my moral duty to announce that I tested positive for COVID19, also known as the Corona Virus. My family and I are and will remain individually isolated for as long as it is medically necessary. Today we all enjoyed good health, but I presented symptoms of coughing and fever, so I decided to take the test and the result was positive," Domingo said.

Domingo has been one of opera's most reliable and bankable stars and is known for his ability to sing tenor and baritone and in multiple languages, including Italian, English, Russian and Spanish.

Recently, the 79-year-old has been embroiled in controversy as several women accused the Spanish-born singer of sexual misconduct.

On March 10, NPR reported that LA Opera, which Domingo helped establish, announced that its investigation substantiated 10 "inappropriate conduct" claims levied against him dating back to as early as 1986. Domingo resigned as the LA Opera's general director in October.

Prior to that, he withdrew from a production of the Metropolitan Opera's performance of "Macbeth" amid allegations of sexual misconduct.

He has denied the allegations.

Domingo is among a growing list of celebrities who have announced they have tested positive for the coronavirus, including actor Tom Hanks and his wife Rita Wilson, actor Idris Elba, NBA star Kevin Durant, talk show host Andy Cohen and British Prime Minister Boris Johnson.

This content is from Southern California Public Radio. View the original story at SCPR.org.

; Credit: John Rabe

Dear Off-Ramp fans,

What is a blog, after all? Words and images.

And what is a radio story on the web? Words, images, and sound.

Can't they live together in harmony? We say YES.

And with that in mind, we're killing the Off-Ramp blog page.  

But don't fear; we're not cutting back on content: everything that would have found a home here - Marc Haefele's art reviews, recommendations for fun events, etc. -- will now be on the regular web page of the Off-Ramp radio show. 

All the old blog entries will continue to stay on this page as an archive, like Catherine Deneuve's fading vampire lovers in The Hunger.

This content is from Southern California Public Radio. View the original story at SCPR.org.

A cleaning crew disinfects a New York City subway train on May 4, 2020 in New York City. ; Credit: Stephanie Keith/Getty Images

As of Monday afternoon, L.A. County has at least 1,260 deaths and 26,238 confirmed cases of coronavirus. The United States has more than a million cases of the virus with more than 67,000 deaths. Meanwhile, new models put together by FEMA project that we could see up to 200,000 new cases a day by the end of the month, according to the New York Times. 

The L.A. Times reports that scientists have discovered a new strain of the deadly coronavirus that is even more contagious. The study finds that the new strain first appeared in February in Europe and has been the dominant strain across the world since mid-March. Plus, some COVID-19 patients are experiencing issues with blood clotting even after respiratory issues have died down. Today on AirTalk, we get the latest with an infectious disease specialist who will take your questions. Call 866-893-5722 to join the conversation. 

With files from LAist. Read the full story here.

Guest:

Dean Blumberg, M.D., professor of medicine and chief of Pediatric Infectious Diseases at UC Davis Children’s Hospital

This content is from Southern California Public Radio. View the original story at SCPR.org.

Phlebotomists process specimens of people getting tested for coronavirus antibodies in Spring Valley. ; Credit: Yana Paskova/Getty Images

As of Tuesday afternoon, L.A. County has at least 1,314 deaths and 27,836 confirmed cases of coronavirus.

New confirmed infections per day in the U.S. exceed 20,000, and deaths per day are well over 1,000,000 according to figures from Johns Hopkins University. And public health officials warn that the failure to flatten the curve and drive down the infection rate in places could lead to many more deaths — perhaps tens of thousands — as people are allowed to venture out and businesses reopen. From the marbled halls of Italy to the wheat fields of Kansas, health authorities are increasingly warning that the question isn’t whether a second wave of coronavirus infections and deaths will hit, but when — and how badly. President Donald Trump said his COVID-19 task force would keep working but focus more on rebooting the economy. According to the Orange County Register, more OC beaches received approval to open with limited hours.

Today on AirTalk, we get the latest on COVID-19. Do you have questions for our infectious disease specialist? Join the conversation by calling 866-893-5722. 

With files from LAist and the Associated Press 

Guest: 

Peter Chin-Hong, M.D., infectious disease specialist and professor of medicine at the UCSF Medical Center; he tweets @PCH_SF

This content is from Southern California Public Radio. View the original story at SCPR.org.

The temperature of a Bolivian child is measured in front of Bolivian embassy during a demonstration requesting repatriation on April 28, 2020 in Santiago, Chile. ; Credit: Marcelo Hernandez/Getty Images

As of Wednesday afternoon, L.A. County has at least 1,367 deaths and 28,646 confirmed cases of coronavirus. Meanwhile, parts of the state are slowly reopening some industries. 

Certain businesses and recreational spaces in Los Angeles County will be allowed to reopen beginning Friday, county officials announced at a media briefing. Those include hiking trails, golf courses, florists, car dealerships and certain retail stores. School districts continue to work through challenges as they consider how to reopen. Kids and teens are coming down with an inflammatory syndrome that experts believe could be linked to COVID-19, NPR News reports. Today on AirTalk, we get the latest on the pandemic with a noted physician, plus we’ll look at the expanding list of symptoms associated with the coronavirus. Are you a parent who has questions about the virus and kids? We want to hear from you. Join the conversation by calling 866-893-5722. 

With files from LAist

Guest:

Richard Jackson, M.D., pediatrician, epidemiologist and professor emeritus at the UCLA Fielding School of Public Health, he’s served in many leadership positions with the California Health Department, including as the State Health Officer, for nine years he served as director of the CDC’s National Center for Environmental Health

This content is from Southern California Public Radio. View the original story at SCPR.org.

The TLC Chinese Theatre is shown on April 11, 2020 in Hollywood, California. ; Credit: Kevin Winter/Getty Images

Last week, L.A. City Councilmember Mitch O’Farrell introduced a motion that would create a taskforce to revitalize on-location television and film production, which went down 18 percent in the first quarter of 2020, thanks to the coronavirus. 

The motion asks Film L.A., the nonprofit that oversees film and TV productions in Los Angeles, to create a taskforce of industry experts who will prepare recommendations for how filming might be resumed safely. It also asks the nonprofit to create a guideline of best practices for on-location filming, as well as protocols regarding sets and facilities. 

We sit down with the president of Film L.A. to discuss what progress has been made and how Hollywood might start up again. 

If you’re in the industry, whether in front of the camera or behind it, tell us about how the pandemic has affected your work life. Can you see a way for filming to resume while following public health best practices? Call ust at 866-893-5722.

Guests:

John Horn, host of KPCC’s “The Frame”; he’s been reporting on the reopening of Hollywood; he tweets @JGHorn

Paul Audley, president of Film L.A., the nonprofit that oversees film and TV productions in Los Angeles

Duncan Crabtree-Ireland, chief operating officer and general counsel of SAG-AFTRA, the union representing media artists; he is currently leading SAG-AFTRA’s “Safety and Reopen Initiative”

This content is from Southern California Public Radio. View the original story at SCPR.org.

Los Angeles City Attorney Mike Feuer, seen here in 2017, says his office has reached a settlement with a company that had been selling at-home tests for the coronavirus. The Food and Drug Administration says it has not authorized any at-home tests.; Credit: Christopher Weber/AP

Mike Feuer, the city attorney of Los Angeles, announced on Monday that his office had "filed a civil law enforcement action against, and achieved an immediate settlement with," a company that had been "illegally selling" an at-home test for the coronavirus.

The Food and Drug Administration has stated that the agency "has not authorized any test that is available to purchase for testing yourself at home for COVID-19."

But in March, Yikon Genomics Inc. offered a coronavirus test for sale online, claiming that the test could be performed "using a simple at-home finger stick blood sample." The company offered tests for $39 each and, in a since-deleted tweet, stated, "Our COVID-19 Test Kit is now FDA APPROVED!"

Yikon's "unlawful, unfair, and fraudulent business acts or practices," the LA city attorney alleged in the lawsuit against the company, "present a continuing threat to members of the public."

At a news conference, Feuer said that FDA validation of tests is crucial because an inaccurate result could lead someone infected with the coronavirus to "unknowingly expose others."

Under the settlement between Yikon and LA authorities, the company agreed to stop marketing or selling home test kits unless they receive FDA approval. Yikon also agreed to provide refunds to anyone who purchased its test kits, though Feuer said it's unclear how many tests were sold.

Yikon Genomics released a statement saying it "is committed to complying with all state & federal laws and regulations regarding the marketing & sale of medical devices. We intend to pursue FDA approval for the market & sale of COVID-19 test kits, which we hope will aid in mitigating this global health crisis."

The Trump administration has said it will "aggressively" prosecute cases of fraud related to the pandemic, and state attorneys general have also pledged to take legal action against scams around the country.

In LA, Feuer said his office continues to investigate other companies' sales of unapproved test kits.

"This is not an isolated incident," Feuer said, noting that his office separately sent a cease-and-desist letter to the California-based Wellness Matrix Group, which, as NPR first reported, had also been offering "at-home" test kits for sale.

"Whenever consumers are motivated in part by fears," the city attorney's office stated in its lawsuit against Yikon, "they are particularly vulnerable to fraudsters, scammers, and 'snake oil' hucksters and charlatans."

This content is from Southern California Public Radio. View the original story at SCPR.org.

Physical and occupational therapists carry bags of personal protective equipment on their way to the room of a COVID-19 patient in a Stamford Hospital intensive care unit in Stamford, Conn., on April 24. This "prone team" turns over COVID-19 to help them breathe.; Credit: John Moore/Getty Images

Intensive care teams inside hospitals are rapidly altering the way they care for patients with COVID-19.

The changes range from new protective gear to new treatment protocols aimed at preventing deadly blood clots.

"Things are moving so fast within this pandemic, it's hard to keep up" says Dr. Angela Hewlett, an infectious diseases physician at University of Nebraska Medical Center in Omaha and medical director of the Nebraska Biocontainment Unit. To stay current, she says, ICUs are updating their practices "on an hourly basis."

"We are learning at light speed about the disease," says Dr. Craig Coopersmith , interim director of the critical care center at Emory University. "Things that previously might have taken us years to learn, we're learning in a week or two. Things that might have taken us a month to learn beforehand, we're learning in a day or two."

The most obvious changes involve measures to protect ICU doctors, nurses and staff from the virus.

"There is a true and real probability of infection," says Dr. Tiffany Osborn a critical care specialist at Washington University School of Medicine and Barnes-Jewish Hospital in St. Louis. "You have to think about everything you touch as if it burned."

So ICUs are adapting measures used at special biocontainment units like the one at the University of Nebraska. These units were designed to care for patients affected by bioterrorism or infected with particularly hazardous communicable diseases like SARS and Ebola.

The Nebraska biocontainment unit "received several patients early on in the pandemic who were medically evacuated from the Diamond Princess cruise ship," Hewlett says. But it didn't have enough beds for the large numbers of local patients who began arriving at the University of Nebraska Medical Center.

So the nurses, respiratory therapists and physicians from the biocontainment team have "fanned out and are now working within those COVID units to make sure that all of our principles and protocols are followed there as well," Hewlett says.

Those protocols involve measures like monitoring ICU staff when they remove their protective gear to make sure the virus isn't transmitted, and placing infected patients in negative pressure rooms, which draw air inward, when possible to prevent the virus from escaping.

One of the riskiest ICU procedures is inserting a breathing tube in a COVID-19 patient's airway, which creates a direct path for virus to escape from a patient's lungs. "If you're intubating a patient, that's a much higher risk than, say, going in and doing routine patient care," Hewlett says.

So ICU teams are being advised to add several layers of protection beyond a surgical mask.

Extra personal protective equipment may include an N95 respirator, goggles, a full face shield, a head hood, an impermeable isolation gown and double gloves.

In many ICUs, teams are also placing a clear plastic box or sheet over the patient's head and upper body before inserting the tube. And as a final safety measure, the doctor may guide the tube using a video camera rather than looking directly down a patient's airway.

"It usually takes 30 minutes or so in order to get all of that equipment together, to get all of the right people there," says Dr. Kira Newman, a senior resident physician at UW Medical Center in Seattle. "and that would be a particularly fast intubation."

But most changes in the ICU are in response to an ongoing flood of new information about how COVID-19 affects the body.

There's a growing understanding, for example, that the infection can cause dangerous blood clots to form in many severely ill patients. These clots can kill if they block arteries supplying the lungs or brain. But they also can prevent blood from reaching the kidneys or even a patient's arms and legs.

Clots are a known risk for all ICU patients, Cooperman says, but the frequency and severity appears much greater with COVID-19. "So we're starting them on a higher level of medicine to prevent blood clots and if somebody actually develops blood clots, we have a plan B and a plan C and a plan D," he says.

ICU teams are also recalibrating their approach to ensuring that patients are getting enough oxygen. Early in the pandemic, the idea was to put patients on mechanical ventilator quickly to make sure their oxygen levels didn't fall too far.

But with experience, doctors have found that mechanical ventilators don't seem to work as well for COVID patients as they do for patients with other lung problems. They've also learned that that many COVID-19 patients remain lucid and relatively comfortable even when the oxygen levels in their blood are extremely low.

So many specialists are now recommending alternatives to mechanical ventilation, even for some of the sickest patients. "We're really trying now to not intubate," Osborn says.

Instead, ICU teams are relying on devices that deliver oxygen through the nasal passages, or through a mask that fits tightly over the face. And there's renewed interest in an old technique to help patients breathe. It's called proning.

"Instead of them being on their back, we're turning them on their front," Osborn says. The reason, she says is to open up a part of the lung that is collapsed when a patient is on their back.

This content is from Southern California Public Radio. View the original story at SCPR.org.

The serious inflammatory syndrome sending some children and teens to the hospital remains extremely uncommon, doctors say. But if your child spikes a high, persistent fever, and has severe abdominal pain and vomiting that doesn't make them feel better, call your doctor as a precaution.; Credit: Sally Anscombe/Getty Images

Sixty-four children and teens in New York State are suspected of having a mysterious inflammatory syndrome that is believed to be linked to COVID-19, the New York Department of Health said in an alert issued Wednesday. A growing number of similar cases — including at least one death — have been reported in other parts of the U.S. and Europe, though the phenomenon is still not well-understood.

Pediatricians say parents should not panic; the condition remains extremely rare. But researchers also are taking a close look at this emerging syndrome, and say parents should be on the lookout for symptoms in their kids that might warrant a quick call to the doctor — a persistent high fever over several days and significant abdominal pains with repeated vomiting, after which the child does not feel better.

"If [the child is] looking particularly ill, you should definitely call the doctor," says Dr. Sean O'Leary, a pediatric infectious disease specialist at Children's Hospital Colorado Anschutz Medical Campus and member of the infectious disease committee for the American Academy of Pediatrics.

The new condition associated with COVID-19 is called Pediatric Multi-System Inflammatory Syndrome. Symptoms include persistent fever, extreme inflammation, and evidence of one or more organs that are not functioning properly, says cardiologist Jane Newburger, a professor of pediatrics at Harvard Medical School and director of the Kawasaki Program at Boston Children's Hospital.

"It's still very rare, but there's been a wave of cases. Physicians and scientists are working hard to understanding the mechanisms at play, and why only some children are so severely affected," Newburger says.

Some symptoms can resemble features of Kawasaki Disease Shock Syndrome. Kawasaki Disease is an acute illness in children involving fever, together with symptoms of rash, conjunctivitis, redness in the lips, tongue and mucous membranes of the mouth and throat, swollen hands and/or feet, and sometimes a large group of lymph nodes on one side of the neck, says Newburger. Some children with the condition develop enlargement of the coronary arteries and aneurysms in those blood vessels.

A small percentage of Kawasaki cases go on to develop symptoms of shock – which can include a steep drop in systolic blood pressure and difficulty with sufficient blood supply to the body's organs. Kawasaki disease and KDSS more often affect young children, although they can sometimes affect teens, Newburger says.

Some cases of the new inflammatory syndrome have features that overlap with KD or with KDSS — including rash, conjunctivitis, and swollen hands or feet. The new inflammatory syndrome can affect not only young children but also older children and teens.

But patients with the new syndrome have lab results that look very different, in particular, "cardiac inflammation to a greater degree than we typically see in Kawasaki shock syndrome," which is usually very rare, O'Leary says. In New York City and London, which have seen large numbers of cases of COVID-19 cases, "those types of patients are being seen with greater frequency."

Some patients "come in very, very sick," with low blood pressure and high fever, O'Leary says. Some children have had coronary artery aneurysms, though most have not, he adds.

Other patients exhibit symptoms more similar to toxic shock syndrome, with abdominal pain, vomiting and diarrhea and high levels of inflammation in the body, as well as the heart, O'Leary says. Most cases are treated in the intensive care unit, he says. Treatment includes intravenous immunoglobulin, which can "calm the immune system," says Newburger, as well as steroids and cytokine blockers.

The evidence so far from Europe, where reports of the syndrome first emerged, suggests most children will recover with proper supportive care, says O'Leary, though one adolescent, a 14-year-old boy in London, has died, according to a report published Wednesday in The Lancet.

Most children with the syndrome, O'Leary and Newburger note, have either tested positive for a current infection with the coronavirus, or for antibodies to the virus, which would suggest they were infected earlier and recovered from it.

And, according to case reports, some of the kids with the inflammatory syndrome who tested negative on coronavirus tests had been exposed at some point to someone known to have COVID-19. The inflammatory syndrome can appear days to weeks after COVID-19 illness, doctors say, suggesting the syndrome arises out of the immune system's response to the virus.

"One theory is that as one begins to make antibodies to SARS-COV-2, the antibody itself may be provoking an immune response," says Newburger. "This is only happening in susceptible individuals whose immune systems are built in a particular way. It doesn't happen in everybody. It's still a really uncommon event in children."

In late April, the U.K.'s National Health Service issued an alert to pediatricians about the syndrome. Reports have also surfaced in France, Spain and Italy, and probably number in the dozens globally, Newburger and O'Leary say, though doctors still don't have hard numbers. Newburger says there needs to be a registry where doctors can report cases "so we can begin to generate some statistics."

"Doctors across countries are talking to each other, but we need for there to be some structure and some science so that everybody can interpret," she says.

Earlier this week, the New York City Health Department issued an alert saying 15 children ranging in age from 2 to 15 had been hospitalized with the syndrome. Newburger says that she's been contacted about cases in New Jersey and Philadelphia, as well.

While the syndrome's precise connection to the coronavirus isn't yet clear, O'Leary says the fact that the children in most of these cases are testing positive for exposure to the virus, one way or another, provides one point of evidence. The sheer number of cases — small in absolute terms, but still "much higher than we would expect normally for things like severe Kawasaki or toxic shock syndrome" — provides another, he says.

And then there's the fact that most reports of the syndrome have come out of the U.K. and New York City, places that have been hit with large numbers of COVID-19 cases.

"It's pure speculation at this point," he says, "but the U.K. cluster kind of went up about a month after their COVID-19 infections went up, which would suggest that it is some kind of an immune phenomenon."

This content is from Southern California Public Radio. View the original story at SCPR.org.

Most people infected with the novel coronavirus develop antibodies in response.

But scientists don't know whether people who have been exposed to the coronavirus will be immune for life, as is usually the case for the measles, or if the disease will return again and again, like the common cold.

"This to me is one of the big unanswered questions that we have," says Jeffrey Shaman, a professor of environmental health sciences at Columbia University, "because it really says, 'What is the full exit strategy to this and how long are we going to be contending with it?' "

He's one of many scientists on a quest for answers. And the pieces are starting to fall into place.

Antibodies, which are proteins found in the blood as part of the body's immune response to infection, are a sign that people could be developing immunity. But they are by no means a guarantee they will be protected for life – or even for a year.

Shaman has been studying four other coronaviruses that cause the common cold. "They're very common and so people seem to get them quite often," Shaman says. Ninety percent of people develop antibodies to those viruses, at least in passing, but "our evidence is those antibodies are not conferring protection."

That may simply because colds are relatively mild, so the immune system doesn't mount a full-blown response, suggests Dr. Stanley Perlman, a pediatrician who studies immunology and microbiology at the University of Iowa. "That's why people get colds over and over again," he says. "It doesn't really tickle the immune response that much."

He's studied one of the most severe coronaviruses, the one that causes SARS, and he's found that the degree of immunity depended on the severity of the disease. Sicker people remained immune for much longer, in some cases many years.

For most people exposed to the novel coronavirus, "I think in the short term you're going to get some protection," Perlman says. "It's really the time of the protection that matters."

Perlman notes that for some people the symptoms of COVID-19 are no worse than a cold, while for others they are severe. "That's why it's tricky," he says, to predict the breadth of an immune response.

And it's risky to assume that experiences with other coronaviruses are directly applicable to the new one.

"Unforutunately, we cannot really generalize what kind of immunity is needed to get protection against a virus unless we really learn more about the virus," says Akiko Iwasaki, a Howard Hughes Medical Institute investigator at the Yale University School of Medicine.

An immunobiologist, she is part of a rapidly expanding effort to figure this out. She and her colleagues are already studying the immune response in more than 100 patients in the medical school hospital. She's encouraged that most people who recover from the coronavirus have developed antibodies that neutralize the coronavirus in a petri dish.

"Whether that's happening inside the body we don't really know," she cautions.

Research like hers will answer that question, eventually.

But not all antibodies are protective. Iwasaki says some can actually contribute to the disease process and make the illness worse. These antibodies can contribute to inflammation and lead the body to overreact. That overreaction can even be deadly.

"Which types of antibodies protect the host versus those that enhance the disease? We really need to figure that out," she says.

The studies at Yale will follow patients for at least a year, to find out how slowly or quickly immunity might fade. "I wish there was a shortcut," Iwasaki says, "but we may not need to wait a year to understand what type of antibodies are protective."

That's because she and other immunologists are looking for patterns in the immune response that will identify people who have long-term immunity.

Researchers long ago figured out what biological features in the blood (called biomarkers) correlate with immunity to other diseases, says Dr. Kari Nadeau, a pediatrician and immunologist at the Stanford University School of Medicine. She expects researchers will be able to do the same for the new coronavirus.

Nadeau is working on several studies, including one that seeks to recruit 1,000 people who were previously exposed to the coronavirus. One goal is to identify people who produce especially strong, protective antibody responses. She says the antibody-producing cells from those people can potentially be turned into vaccines.

Another critical question she's zeroing in on is whether people who become immune are still capable of spreading the virus.

"Because you might be immune, you might have protected yourself against the virus," she says, "but it still might be in your body and you're giving it to others."

That would have huge public health implications if it turns out people can still spread the disease after they've recovered. Studies from China and South Korea seemed to suggest this was possible, though further studies have cast doubt on that as a significant feature of the disease.

Nadeau is also trying to figure out what can be said about the antibody blood-tests that are now starting to flood the market. There are two issues with these tests. First, a positive test may be a false-positive result, so it may be necessary to run a confirmatory test to get a credible answer. Second, it's not clear that a true positive test result really indicates a person is immune, and if so for how long.

Companies would like to be able to use these tests to identify people who can return to work without fear of spreading the coronavirus.

"I see a lot of business people wanting to do the best for their employees, and for good reason," Nadeau says. "And we can never say you're fully protected until we get enough [information]. But right now we're working hard to get the numbers we need to be able to see what constitutes protection and what does not."

It could be a matter of life or death to get this right. Answers to these questions are likely to come with the accumulation of information from many different labs. Fortunately, scientists around the world are working simultaneously to find answers.

You can contact NPR Science Correspondent Richard Harris at rharris@npr.org.

This content is from Southern California Public Radio. View the original story at SCPR.org.

Remdesivir, an experimental antiviral drug made by Gilead Sciences, has been authorized by the Food and Drug Administration for emergency use in treating severely ill COVID-19 patients.; Credit: Ulrich Perry/POOL/AFP via Getty Images

Now that the Food and Drug Administration has authorized remdesivir for emergency use in seriously ill COVID-19 patients, the experimental drug is another step closer to full approval. That's when most drugs get price tags.

Gilead Sciences, which makes remdesivir, is donating its initial supply of 1.5 million doses, but the company has signaled it will need to start charging for the drug to make production sustainable. It's unclear when that decision might be made.

"Going forward, we will develop an approach that is guided by the principles of affordability and access," Gilead CEO Daniel O'Day told shareholders during the company's annual meeting Wednesday.

In a quarterly financial filing made the same day, Gilead said its investment in remdesivir this year "could be up to $1 billion or more," much of it for scaling up manufacturing capacity.

The company also acknowledged that it's in the spotlight. "[G]iven that COVID-19 has been designated as a pandemic and represents an urgent public health crisis, we are likely to face significant public attention and scrutiny about any future business models and pricing decisions with respect to remdesivir," Gilead said in the quarterly filing.

How will the company balance its business calculations with the drug's potential value to society?

"Gilead has not yet set a price for remdesivir," company spokeswoman Sonia Choi wrote in an email to NPR. "At this time, we are focused on ensuring access to remdesivir through our donation. Post-donation, we are committed to making remdesivir both accessible and affordable to governments and patients around the world."

Among potential treatments for COVID-19, remdesivir, an intravenous drug that was once studied for Ebola, is one of the furthest along.

"It's hard to imagine a situation in which there will be more public scrutiny," said Michael Carrier, a professor at Rutgers School of Law who specializes in antitrust and pharmaceuticals. "On the one hand, Gilead will try to recover its R&D in an atmosphere in which it is able to potentially make a lot of money. On the other hand, the pressure will be intense not to charge what's viewed as too high a price."

Breaking with its usual practices, the Institute for Clinical and Economic Review, or ICER, an influential nonprofit that analyzes drug pricing, issued an expedited report on remdesivir.

"Under normal circumstances, we would be unlikely to do a report when the evidence is this raw and immature," ICER President Steven Pearson said in an interview with NPR. "But it was quite clear that the world is moving at a much quicker pace."

If the price is based just on the cost of making the drug, then a 10-day course of remdesivir should cost about $10, according to the ICER report. (Gilead said results of a recently completed study suggest a five-day course of treatment may be just as effective.)

But if the drug is priced based on the drug's effectiveness, ICER estimates it should cost around $4,500 — assuming the drug is proven to have some benefit on mortality. If it doesn't and the drug only shortens hospital stays, that value-based price goes down to $390.

Results from a federally funded study described by Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, suggested that remdesvir could reduce recovery time by a median of four days — 11 days to recovery for patients treated with remdesivir compared with 15 days for those who got a placebo. A potential survival benefit is less clear.

Rutgers's Carrier said he expects Gilead to set the remdesivir price somewhere between the $10 and $4,500 that ICER estimated. The company has already shown that it can respond to public pressure when it asked the FDA to rescind the orphan drug status it won for remdesivir, he pointed out.

"When you see that $10 figure, that sets a benchmark for a figure that is eminently affordable," Carrier said. Ultimately, he said a price more than $1,000 per treatment course would be unpopular.

Gilead "will be watched very carefully," he said, because of its prior history of pricing. He referred to two other Gilead drugs that drew scrutiny over high price tags. The company charged $1,000 per pill for Sovaldi, a cure for hepatitis C. And its HIV drug Truvada can cost $22,000 per year.

But there is such a thing as pricing remdesivir too low, said Craig Garthwaite, who directs the health care program at Northwestern University's Kellogg School of Management.

"We don't think this is the only drug we need," he said, adding that remdesivir doesn't appear to be a "home run" against the coronavirus, based on existing data. "The thing that would worry me the most is that we're somehow telling people that if you take the risky bet to try, and you'll go after a coronavirus cure and you do it, you're not going to get paid."

Instead, he said he would like to see acceptance of a generous price for remdesivir to send the message to drug companies that the best thing they can do is "dedicate every waking moment to trying to develop that cure, and that if they do that, we will pay them the value they create," he said.

During a Gilead earnings call on April 30, analysts asked executives whether they could expect similar financial returns on remdesivir as they've seen with Gilead's other drugs.

"There is no rulebook out there, other than that we need to be very thoughtful about how we can make sure we provide access of our medicines to patients around the globe," Gilead CEO O'Day said. "And do that in a sustainable way for the company, for ... shareholders, and we acknowledge that."

On May 1, the FDA authorized remdesivir for emergency use, meaning it will be easier to administer to hospitalized patients with severe disease during the pandemic, but the drug is not yet officially approved. The federal government is coordinating distribution of the treatment.

Day acknowledged on the recent earnings call that the company "could" charge for remdesivir under an emergency use authorization, but he stressed that Gilead is donating its current supply, which should last through "early summer."

To date, the National Institutes of Health said it has obligated $23 million toward its COVID-19 remdesivir trial. And the U.S. Army Medical Research Institute of Infectious Diseases did some of the early in vitro and animal studies with the medicine prior to the pandemic.

"Taxpayers are often the angel investors in pharmaceutical research and development, yet this is not reflected in the prices they pay," Reps. Lloyd Doggett, D-Texas, and Rosa DeLauro, D-Conn., wrote in a April 30 letter to Health and Human Services Secretary Alex Azar.

Concerned about remdesivir's price, they asked for a full breakdown of taxpayer funds that have gone toward the development of the medicine. "An unaffordable drug is completely ineffective," they wrote in the letter. "The substantial taxpayer investments in COVID-19 pharmaceutical research must be recognized."

This content is from Southern California Public Radio. View the original story at SCPR.org.

A woman wearing a mask walks past closed store fronts in the Astoria neighborhood of Queens on April 15 in New York City. States are beginning to implement phased reopening plans, in part to help businesses hit hard by the coronavirus.; Credit: Johannes Eisele/AFP via Getty Images

President Trump wants states to begin relaxing stay-at-home orders and reopen businesses after the spread of the coronavirus pummeled the global economy and killed millions of jobs.

The White House coronavirus task force released guidelines on April 16 to encourage state governors to adopt a phased approach to lifting restrictions across the country. Some states have moved ahead without meeting the criteria.

The task force rejected a set of additional detailed draft recommendations for schools, restaurants, churches and mass transit systems from the Centers for Disease Control and Prevention that it considered "overly prescriptive."

A number of states have already begun to lift restrictions, allowing for businesses including hair salons, diners and tattoo parlors to once again begin accepting customers. Health experts have warned that reopening too quickly could result in a potential rebound in cases.

States are supposed to wait to begin lifting any restrictions until they have a 14-day "downward trajectory" of influenza-like illnesses and confirmed virus cases, as well as sufficient hospital capacity and testing for health care workers.

Below is a summary of the three phases as outlined by the task force (read the full guidance here):

Don't see the graphic above? Click here.

This content is from Southern California Public Radio. View the original story at SCPR.org.

COVID-19 Research and Development Sean's pick this week is COVID-19 Research and Development by MathWorks. We were recently introduced to this page which highlights uses of... read more >>

U.S. Rep. Adam Schiff (D-CA) listens during a news conference in front of the U.S. Capitol.; Credit: Alex Wong/Getty Images

As we discussed last week on FilmWeek, entertainment industry professionals are among the hardest hit amid the stoppage of everyday work and life due to COVID-19. Whether you’re on camera or stage, or behind it, above the line or below it, production shutdowns mean that industry professionals who already rely on sporadic work as it’s available are left with few to no options for sustainable income. 

Last week, Congressman Adam Schiff and other members of Congress who represent areas with large constituencies that work in the entertainment industry sent a letter to House leaders asking them to provide relief for both freelance and contract entertainment industry workers. “The unique freelance nature of work in film, television, theater, and live music means that a large number of the professionals who make these productions possible work only sporadically—often with extended periods between paying jobs—and count on income from each project to make ends meet,” the letter said in part. “As a result, many of them can’t qualify for traditional unemployment benefits or paid emergency leave, yet will now be unable to cover their basic expenses due to lost work.” 

Today on AirTalk, Congressman Schiff joins us to talk about what relief both freelance and contract entertainment industry professionals can expect if the House passes the stimulus package that would provide financial aid to Americans during the coronavirus pandemic. 

Guest: 

Adam Schiff, U.S. Congressman representing California’s 28th Congressional District, which includes Burbank, parts of Pasadena, and Glendale, and chairman of the House Intelligence Committee; he tweets @RepAdamSchiff

This content is from Southern California Public Radio. View the original story at SCPR.org.

Closing Night Party at last year's 2019 TCM 10th Annual Classic Film Festival in Hollywood, California. ; Credit: Presley Ann/Getty Images for TCM

Like all public events following the start of widespread stay-at-home orders from the state and federal government, the 2020 TCM Classic Film Festival was unfortunately cancelled this year due to health concerns posed by COVID-19. But festival faithful and classic film buffs won’t be left hanging this year.

Instead of a live, in person event, TCM decided to do a Special Home Edition of the annual festival that will air on the TCM Channel. The festival kicked off Thursday evening with a screening of the 1954 version of “A Star is Born” starring Judy Garland and James Mason and will include a number of films from past years’ festival lineups as well as ones that were slated for this year’s event. It ends late Sunday night (technically early Monday morning) with a screening of the 1982 film Victor/Victoria, for which Julie Andrews was slated to be in attendance at the 2020 festival before it was cancelled.

Today on FilmWeek, Turner Classic Movies hosts Ben Mankiewicz and Dave Karger join Larry Mantle to preview this year’s Special Home Edition of the TCM Classic Film Festival, talk about having to pivot due to the pandemic, and sharing some of their favorite films that are screening at this year’s event.

For a list of films and showtimes, click here.

Guests:

Ben Mankiewicz, host for Turner Classic Movies; he tweets @BenMank77

Dave Karger, host for Turner Classic Movies and special correspondent for the Internet Movie Database (IMDb); he tweets @DaveKarger

This content is from Southern California Public Radio. View the original story at SCPR.org.

Brad Bird accepts the Best Animated Feature Award for Incredibles 2 during The National Board of Review Annual Awards Gala at Cipriani 42nd Street on January 8, 2019 in New York City. ; Credit: Dia Dipasupil/Getty Images for National Board

Brad Bird has made a name for himself as the director of new age, animated classics, like “The Iron Giant” and “The Incredibles”. Now he’s teaming up with Turner Classic Movies to share his picks for classic movie watching that will keep you busy and entertained while you’re stuck at home.

Bird has curated a list of his favorite films which will air on this season’s “The Essentials” with TCM Primetime host Ben Mankiewicz. Every Saturday from May up to January of next year, TCM will air one of twenty movies chosen by Bird. His list includes big-name classics that any movie buff will recognize, like “Casablanca” and “Dr. Strangelove”. But Bird throws in a few surprises, one being that there are no animated films on his list. Another surprising thing viewers will notice is that about a third of the films included are musicals, like “Singin’ In The Rain” and “Guys And Dolls”. With TCM’s seemingly infinite library of movie classics to choose from, Bird says narrowing it down to only twenty favorites was a challenge. According to Bird, his list comprises movies that are not only entertaining but “transcend time” and “speak in a language that is still in many ways current”.

“The Essentials” was filmed in early December, but Bird’s list is coming out during a time when movie-going is looking very different these days. The virus has put the entire film industry on pause, with studios halting production and theaters closing their doors indefinitely. In lieu of new movie releases and regular theater-going, many are taking the opportunity to revisit the classics and Bird’s list provides a starting guide for which ones should be on your watch-list.

Today on FilmWeek, Brad Bird joins us to talk about his favorite movies, what projects he has lined up, and his thoughts on how the film industry is adjusting to and getting through the pandemic.

TCM’s “The Essentials” will air on Saturdays at 8 p.m. beginning May 2. For the full list and schedule of films, click here.

Guest:

Brad Bird, animator, director and screenwriter whose directing credits include Pixar’s “Ratatouille” and “The Incredibles” films and Disney’s “The Iron Giant”; he tweets at @BradBirdA113

This content is from Southern California Public Radio. View the original story at SCPR.org.

Remdesivir, an experimental antiviral drug made by Gilead Sciences, has been authorized by the Food and Drug Administration for emergency use in treating severely ill COVID-19 patients.; Credit: Ulrich Perry/POOL/AFP via Getty Images

Now that the Food and Drug Administration has authorized remdesivir for emergency use in seriously ill COVID-19 patients, the experimental drug is another step closer to full approval. That's when most drugs get price tags.

Gilead Sciences, which makes remdesivir, is donating its initial supply of 1.5 million doses, but the company has signaled it will need to start charging for the drug to make production sustainable. It's unclear when that decision might be made.

"Going forward, we will develop an approach that is guided by the principles of affordability and access," Gilead CEO Daniel O'Day told shareholders during the company's annual meeting Wednesday.

In a quarterly financial filing made the same day, Gilead said its investment in remdesivir this year "could be up to $1 billion or more," much of it for scaling up manufacturing capacity.

The company also acknowledged that it's in the spotlight. "[G]iven that COVID-19 has been designated as a pandemic and represents an urgent public health crisis, we are likely to face significant public attention and scrutiny about any future business models and pricing decisions with respect to remdesivir," Gilead said in the quarterly filing.

How will the company balance its business calculations with the drug's potential value to society?

"Gilead has not yet set a price for remdesivir," company spokeswoman Sonia Choi wrote in an email to NPR. "At this time, we are focused on ensuring access to remdesivir through our donation. Post-donation, we are committed to making remdesivir both accessible and affordable to governments and patients around the world."

Among potential treatments for COVID-19, remdesivir, an intravenous drug that was once studied for Ebola, is one of the furthest along.

"It's hard to imagine a situation in which there will be more public scrutiny," said Michael Carrier, a professor at Rutgers School of Law who specializes in antitrust and pharmaceuticals. "On the one hand, Gilead will try to recover its R&D in an atmosphere in which it is able to potentially make a lot of money. On the other hand, the pressure will be intense not to charge what's viewed as too high a price."

Breaking with its usual practices, the Institute for Clinical and Economic Review, or ICER, an influential nonprofit that analyzes drug pricing, issued an expedited report on remdesivir.

"Under normal circumstances, we would be unlikely to do a report when the evidence is this raw and immature," ICER President Steven Pearson said in an interview with NPR. "But it was quite clear that the world is moving at a much quicker pace."

If the price is based just on the cost of making the drug, then a 10-day course of remdesivir should cost about $10, according to the ICER report. (Gilead said results of a recently completed study suggest a five-day course of treatment may be just as effective.)

But if the drug is priced based on the drug's effectiveness, ICER estimates it should cost around $4,500 — assuming the drug is proven to have some benefit on mortality. If it doesn't and the drug only shortens hospital stays, that value-based price goes down to $390.

Results from a federally funded study described by Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, suggested that remdesvir could reduce recovery time by a median of four days — 11 days to recovery for patients treated with remdesivir compared with 15 days for those who got a placebo. A potential survival benefit is less clear.

Rutgers's Carrier said he expects Gilead to set the remdesivir price somewhere between the $10 and $4,500 that ICER estimated. The company has already shown that it can respond to public pressure when it asked the FDA to rescind the orphan drug status it won for remdesivir, he pointed out.

"When you see that $10 figure, that sets a benchmark for a figure that is eminently affordable," Carrier said. Ultimately, he said a price more than $1,000 per treatment course would be unpopular.

Gilead "will be watched very carefully," he said, because of its prior history of pricing. He referred to two other Gilead drugs that drew scrutiny over high price tags. The company charged $1,000 per pill for Sovaldi, a cure for hepatitis C. And its HIV drug Truvada can cost $22,000 per year.

But there is such a thing as pricing remdesivir too low, said Craig Garthwaite, who directs the health care program at Northwestern University's Kellogg School of Management.

"We don't think this is the only drug we need," he said, adding that remdesivir doesn't appear to be a "home run" against the coronavirus, based on existing data. "The thing that would worry me the most is that we're somehow telling people that if you take the risky bet to try, and you'll go after a coronavirus cure and you do it, you're not going to get paid."

Instead, he said he would like to see acceptance of a generous price for remdesivir to send the message to drug companies that the best thing they can do is "dedicate every waking moment to trying to develop that cure, and that if they do that, we will pay them the value they create," he said.

During a Gilead earnings call on April 30, analysts asked executives whether they could expect similar financial returns on remdesivir as they've seen with Gilead's other drugs.

"There is no rulebook out there, other than that we need to be very thoughtful about how we can make sure we provide access of our medicines to patients around the globe," Gilead CEO O'Day said. "And do that in a sustainable way for the company, for ... shareholders, and we acknowledge that."

On May 1, the FDA authorized remdesivir for emergency use, meaning it will be easier to administer to hospitalized patients with severe disease during the pandemic, but the drug is not yet officially approved. The federal government is coordinating distribution of the treatment.

Day acknowledged on the recent earnings call that the company "could" charge for remdesivir under an emergency use authorization, but he stressed that Gilead is donating its current supply, which should last through "early summer."

To date, the National Institutes of Health said it has obligated $23 million toward its COVID-19 remdesivir trial. And the U.S. Army Medical Research Institute of Infectious Diseases did some of the early in vitro and animal studies with the medicine prior to the pandemic.

"Taxpayers are often the angel investors in pharmaceutical research and development, yet this is not reflected in the prices they pay," Reps. Lloyd Doggett, D-Texas, and Rosa DeLauro, D-Conn., wrote in a April 30 letter to Health and Human Services Secretary Alex Azar.

Concerned about remdesivir's price, they asked for a full breakdown of taxpayer funds that have gone toward the development of the medicine. "An unaffordable drug is completely ineffective," they wrote in the letter. "The substantial taxpayer investments in COVID-19 pharmaceutical research must be recognized."

This content is from Southern California Public Radio. View the original story at SCPR.org.

World War II veterans Pyotr Vorobyev (left), 90, and Pavel Yeroshenko, 94, attend a performance in Minsk by the 120th Rogachev Guards Mechanized Brigade of the Belarusian Armed Forces ahead of the 75th anniversary of the victory in World War II. Belarus is raising eyebrows — and concerns — by going ahead with a mass military parade marking the anniversary on Saturday.; Credit: Natalia Fedosenko/TASS

With the coronavirus forcing much of Europe to tone down public celebrations this week marking the 75th anniversary of the end of World War II, the small nation of Belarus is raising eyebrows — and concerns — by going ahead with a mass military parade in the capital Minsk on Saturday.

The move reflects the business-as-usual approach of the country's longtime president, Alexander Lukashenko — a former Soviet collective farm director leading what the U.S. once dubbed the last dictatorship in Europe.

As the coronavirus has raced across the globe, Lukashenko has dismissed the pandemic as mass "psychosis" — a disease easily cured with a bit of vodka, a hot sauna or time spent playing hockey or doing farm work on one of country's legendary Soviet-designed tractors.

The country's soccer league still competes. Belarus' schools opened after a short delay. And annual Victory Day celebrations will go on.

The government "simply cannot cancel the parade," the Belarusian leader said in a Cabinet meeting this week. "It's an emotional, deeply ideological event."

In a rare concession to at least some social distancing measures, Lukashenko has urged Belarusian men to spend time with their families, rather than their mistresses. But behind the theatrics sits a wily politician who plays to his base in the country's towns and villages, analysts say.

"Lukashenko prioritizes combating panic rather than combating the pandemic," Artyom Shraibman, a Minsk-based political analyst with Sense Analytics, tells NPR. "He downplays the threat, and of course he's very concerned about [the] state of [the] economy."

Shraibman notes similar echoes coming out of the Trump White House.

Belarus has reported over 21,000 suspected coronavirus cases and more than 120 deaths — comparatively low in the global count, but one of the fastest-growing infection rates in Europe, the World Health Organization says.

Amid the growing crisis, Belarusian civil society is rallying to fix what Lukashenko will not. With many Belarusians now self-isolating by choice, even the country's health ministry has endorsed some public distancing measures over Lukashenko's advice.

Volunteers have raised money to buy personal protective gear for hospitals. Restaurants have donated food. Hotels provide rooms pro bono to medical workers. Private businesses have raised funds.

"People who normally don't talk to each other are working together to help," says Andrej Stryzhak of #ByCovid19, a group of volunteer activists leading crowdfunded efforts to equip health workers across the country. "It's been magical and I don't use that word lightly."

Stryzhak says many are bracing for the aftershocks of Saturday's Victory parade, where attendance isn't required but there are reports of pay bonuses given to those who show up.

"We believe in statistics. And the experts and doctors tell us that if there's a crowd, then expect a new spike in cases a week or two later," says Stryzhak. "Belarus isn't Mars," he adds, noting that the country is as susceptible to the virus as any other.

Meanwhile, Lukashenko's contrarian approach has also fueled a rift with Belarus' big brother to the east. Russia has embraced lockdowns amid its own soaring coronavirus infection rates.

This week, the Belarusian leader ordered the expulsion of a journalist from Russia's Channel 1 state television network after it aired a report criticizing Lukashenko for risking lives and ignoring the pandemic.

"Leave us alone and don't count your chickens before they hatch," said Lukashenko. "Later we'll sit and find out who was right."

This content is from Southern California Public Radio. View the original story at SCPR.org.

A woman wearing a mask walks past closed store fronts in the Astoria neighborhood of Queens on April 15 in New York City. States are beginning to implement phased reopening plans, in part to help businesses hit hard by the coronavirus.; Credit: Johannes Eisele/AFP via Getty Images

President Trump wants states to begin relaxing stay-at-home orders and reopen businesses after the spread of the coronavirus pummeled the global economy and killed millions of jobs.

The White House coronavirus task force released guidelines on April 16 to encourage state governors to adopt a phased approach to lifting restrictions across the country. Some states have moved ahead without meeting the criteria.

The task force rejected a set of additional detailed draft recommendations for schools, restaurants, churches and mass transit systems from the Centers for Disease Control and Prevention that it considered "overly prescriptive."

A number of states have already begun to lift restrictions, allowing for businesses including hair salons, diners and tattoo parlors to once again begin accepting customers. Health experts have warned that reopening too quickly could result in a potential rebound in cases.

States are supposed to wait to begin lifting any restrictions until they have a 14-day "downward trajectory" of influenza-like illnesses and confirmed virus cases, as well as sufficient hospital capacity and testing for health care workers.

Below is a summary of the three phases as outlined by the task force (read the full guidance here):

Don't see the graphic above? Click here.

This content is from Southern California Public Radio. View the original story at SCPR.org.

Money manager Adrian Day provides updates on some of the resource companies in his portfolio and says he is buying little, but is ready to buy on pullbacks.

(Stock photo); Credit: Meathead Movers/flickr Creative Commons

As of today, KPCC is moving Breakdown coverage to our main business page, where you will find KPCC’s ongoing news and information about Southern California business and the economy.

As a result, the Breakdown blog will no longer be updated. All previous Breakdown posts will remain available here as an archive.

Please let us know if there are issues you feel merit coverage. You can comment below, by email, on our Facebook page or on our Twitter feed (just "@" mention @KPCC).

This content is from Southern California Public Radio. View the original story at SCPR.org.

The users' personal data are now up for grabs on the dark web for anywhere between US$3,500 and US$22,000 worth of bitcoin

The post 600,000 people affected in email provider breach appeared first on WeLiveSecurity

The tool, which comes after a similar effort by Google, looks at how people’s traveling behavior has changed since the start of the pandemic

The post Apple releases mobility data to help combat COVID‑19 appeared first on WeLiveSecurity

The pandemic has highlighted the need for businesses to act with alacrity and prepare for the long haul – and to do so with cybersecurity in mind

The post Digital transformation could be accelerated by COVID‑19 appeared first on WeLiveSecurity

Source: Streetwise Reports   04/22/2020

In an April 19 research note, ROTH Capital Partners analyst Yasmeen Rahimi reported that the Biomedical Advanced Research and Development Authority (BARDA) awarded Moderna Inc. (MRNA:NASDAQ) $483 million in funding, in part for development of its COVID-19 vaccine, mRNA-1273.

Rahimi discussed how Massachusetts-based Moderna will use the funds, which will be provided in tranches to reach certain milestones.

Half of the $483 million award will be used to help cover clinical development costs of mRNA-1273, from trial operations to the filing of a biologics license application.

Currently, the vaccine is in Phase 1 in the clinic. Recently, the biopharma decided to add to the study a cohort of patients aged 51 years and up, which "will be key for demonstrating mRNA-1273's safety and immunogenicity in this vulnerable population," Rahimi noted.

The analyst explained that for mRNA-1273 to advance to Phase 2, the results from Phase 1 must be optimal. The data must demonstrate the vaccine is safe and tolerable. They must show that the vaccine produced a sufficient number of neutralizing antibodies, crucial for stopping viral replication and proving the vaccine's method of action. Phase 1 safety data from the group aged 18–55 years are expected in spring followed by immunogenicity results, likely in mid-July or early August.

Rahimi relayed that as soon as safety data are available, Moderna plans to launch a Phase 2 study of mRNA-1273 rather than wait for the remaining results to become available, according to CEO Stéphane Bancel.

"Pending favorable safety data from Phase 1, we point out that a potential Phase 2 study would enroll hundreds of patients, and that the BARDA funding could potentially allow Moderna to pursue trials in patient populations who are at greater risk, such as patients who have underlying comorbidities, those who are overweight and patients with cancer," commented Rahimi.

Moderna will spend the second half of the $483 million BARDA funding on the engineering and optimization work required to scale up the manufacturing of its messenger RNA (mRNA).

"With the current focus on SARS-CoV-2 and mRNA-1273, Moderna was now able to present BARDA its strategic plans (amount, time and people) of how to be ready for commercial launch," wrote Rahimi. "This preparation was likely helpful in expediting discussions with BARDA and awarding of the grant."

Also regarding mRNA production, Ginkgo Bioworks, a company with expertise in organism biology and genetically engineering bacteria to replace certain industrial applications, is helping Moderna optimize certain parts of the process.

Rahimi, who is closely tracking COVID-19 data, highlighted that April 18 was the first day in five on which the daily death tally, 1,867, was less than that predicted by Dr. Christopher Murray's model, 2,194.

ROTH has a Buy rating on Moderna.

Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

Disclosures from ROTH Capital Partners, Moderna Inc., Company Note, April 19, 2020

Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

Within the last twelve months, ROTH has received compensation for investment banking services from Moderna, Inc.

ROTH makes a market in shares of Moderna, Inc. and as such, buys and sells from customers on a principal basis.

Within the last twelve months, ROTH has managed or co-managed a public offering for Moderna, Inc.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.

( Companies Mentioned: MRNA:NASDAQ, )

Source: Streetwise Reports   04/24/2020

Mesoblast Ltd. (MESO:NASDAQ; MSB:ASX) today announced that it had achieved an "83% survival in ventilator-dependent COVID-19 patients (10/12) with moderate/severe acute respiratory distress syndrome (ARDS) treated during the period March-April 2020 with two intravenous infusions of Mesoblast's allogeneic mesenchymal stem cell product candidate remestemcel-L within the first five days." The company stated that of the 12 patients treated, 75% (9/12) successfully came off ventilator support after a median timeframe of 10 days. The firm advised that all of the patients were treated under an emergency Investigational New Drug (IDA) application or expanded access protocol at Mt. Sinai hospital in New York City and so far seven of the patients have been discharged from the hospital. The company noted that each of the patients had received a variety of experimental agents prior to being treated with remestemcel-L.

The firm explained that until now only about 9% (38/445) of ventilator-dependent COVID-19 patients at a major referral hospital network in New York City were able to come off ventilator support when treated with existing standard of care treatments during March and April 2020. The company reported that at a second major referral hospital network in New York City over the same period, there was 88% mortality with only 12% survival (38/320) among ventilator-dependent COVID-19 patients.

The company's CEO Dr. Silviu Itescu commented, "The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent in cytokine release syndromes associated with high mortality, including acute graft versus host disease and COVID-19 ARDS. We intend to rapidly complete the randomized, placebo-controlled Phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients."

Dr. Fred Grossman, Mesoblast's Chief Medical Officer, added, "There is a significant need to improve the dismal survival outcomes in COVID-19 patients who progress to ARDS and require ventilators. We have implemented robust statistical analyses in our Phase 2/3 trial as recommended by the US Food and Drug Administration (FDA) in order to maximize our ability to evaluate whether remestemcel-L provides a survival benefit in moderate/severe COVID-19 ARDS."

Mesoblast Ltd. is headquartered in Melbourne, Australia, and is a developer of industrial-scale, cryopreserved, off-the-shelf allogeneic cellular medicines. The company utilizes its proprietary mesenchymal lineage cell therapy technology platform in order to create a wide portfolio of commercial products and late-stage product candidates. The firm indicated that "the Biologics License Application to seek approval of its product candidate RYONCIL™ (remestemcel-L) for steroid-refractory acute graft versus host disease has been accepted for priority review by the U.S. Food and Drug Administration." The company has offices in Australia, the U.S. and Singapore.

Mesoblast began the day with a market capitalization of around $687.9 million with approximately 106.7 million shares outstanding. MESO shares opened nearly 142% higher today at $15.59 (+$9.14, +141.71%) over yesterday's $6.45 closing price and reached a new 52-week high price this morning of $20.57. The stock has traded today between $13.01 and $20.57 per share and is presently trading at $14.76 (+$8.30, +128.76%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: MESO:NASDAQ; MSB:ASX, )

Source: Streetwise Reports   04/29/2020

Biopharmaceutical company Chimerix Inc. (CMRX:NASDAQ), which focuses on developing medicines to treat cancer and other serious diseases, today announced that it will initiate a Phase 2/3 study of dociparstat sodium (DSTAT) in COVID-19 patients suffering from acute lung injury (ALI).

The firm explained that "DSTAT is a glycosaminoglycan derivative of heparin with robust anti-inflammatory properties, including the potential to address underlying causes of coagulation disorders with substantially reduced risk of bleeding complications compared to commercially available forms of heparin.^"

Joseph Lasky, M.D., Professor of Medicine, Pulmonary and Critical Care Section Chief, John W. Deming, M.D. Endowed Chair in Internal Medicine at Tulane University Medical School commented, "Given the severity of the COVID-19 pandemic, we have evaluated many potential targets to address the clinical manifestations associated with severe COVID-19...Based on the literature, we believe DSTAT has the potential to reduce the excessive inflammation, immune cell infiltration and hypercoagulation associated with poor outcomes in patients with severe COVID-19 infection."

The company's CEO Mike Sherman remarked, " DSTAT is well-suited to unlock the anti-inflammatory properties of heparin as it may be dosed at much higher levels than any available form of heparin without triggering bleeding complications...We had planned to evaluate DSTAT in several indications of high unmet need, including ALI from different causes. The pandemic intensified our focus on ALI associated with COVID-19. Our team has worked closely with critical care physicians treating COVID-19 patients and with the U.S. Food and Drug Administration (FDA) to develop a Phase 2/3 protocol to determine if DSTAT can reduce the need for mechanical ventilation and improve the rate of survival in patients with severe COVID-19 infection."

The company outlined its plans for the study indicating that it will be a randomized, double-blind Phase 2/3 trial to determine the safety and efficacy of DSTAT in adults with severe COVID-19 who are at a high risk of respiratory failure. The study subjects will be confirmed COVID-19 patients who require hospitalization and supplemental oxygen therapy. The primary endpoint established in the study is the percentage of subjects who survive and do not require mechanical ventilation through 28 days. Several secondary endpoints listed include time needed for showing improvement, time to hospital discharge, time to resolution of fever, number of ventilator-free days, all-cause mortality and changes in several key biomarkers.

The study will begin by enrolling 24 subjects in Phase 2 to first establish dosage levels and then expand to 74 total patients. The firm advised that if Phase 2 results are positive, it would enroll approximately 450 subjects in the Phase 3 portion of the study.

The company reported that "the clinical manifestations of COVID-19 range from mild, self-limited respiratory tract illness to severe alveolar damage and progressive respiratory failure, multiple organ failure, and death. Mortality in COVID-19 is associated with severe pulmonary disease and coagulation disorders such as disseminated intravascular coagulation." The firm indicated that the mechanisms of action of DSTAT may address overactive inflammatory response including underlying causes of blood coagulation disorders associated with COVID-19.

Chimerix is a development-stage biopharmaceutical company based in Durham, N.C. which is engaged in advancing medicines in the areas of cancer and other serious diseases. The company listed that it presently has two active clinical-stage development programs. The first is dociparstat sodium (DSTAT) which is a glycosaminoglycan compound derived from porcine heparin that has low anticoagulant activity. The second pipeline candidate is brincidofovir (BCV) which is an antiviral drug being developed as a medical countermeasure for smallpox.

Chimerix began the day with a market capitalization of around $93.2 million with approximately 61.74 million shares outstanding. CMRX shares opened 30% higher today at $1.97 (+$0.46, +30.46%) over yesterday's $1.51 closing price. The stock has traded today between $1.82 to $2.62 per share and is currently trading at $2.27 (+$0.76, +50.33%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: CMRX:NASDAQ, )

Source: Streetwise Reports   05/06/2020

Testing has been an Achilles heel of the coronavirus pandemic, but ProMIS Neurosciences Inc. (PMN:TSX; ARFXF:OTCQB) has partnered with Dr. Hans Frykman and the BC Neuroimmunology Lab to use its unique technology to create a more accurate antibody test for SARS-CoV-2, the virus that causes Covid-19.

Two main types of tests exist for Covid-19: one that detects the presence of the virus that causes Covid-19, which indicates a person has an active infection, and another that detects antibodies, showing that a person has been exposed to the virus.

The first test that was developed, a test for the presence of the virus, is used mainly to confirm diagnosis of Covid-19 in people who are showing symptoms such as a fever, a dry, persistent cough, difficulty breathing, a sense of restriction in the chest. "They are typical signs of Covid-19, but we would want to know if these are signs of the common flu or a bad cold or Covid-19. We know that Covid can progress really significantly very quickly, especially in individuals with underlying conditions," ProMIS CEO Dr. Elliot Goldstein told Streetwise Reports. "The number of tests is limited, but it's not actually the tests themselves but the reagents and systems you need to run the test that are in short supply."

"Anytime you conduct a test for the virus and get a negative response, the test indicates only that on that day at that time, the person does not have the virus. The person could have had Covid and recovered, or might have had an asymptomatic or very mild case. Or that person could get the virus tomorrow or in three days," Dr. Goldstein explained. "At any point in time the virus test helps indicate the prevalence of the virus—how many people are actually infected—if you test broadly, and at the time you do it, you can determine whether an individual is currently infected or not."

The second type of test, called serological tests or assays, is also known as an antibody test. "When a person is recovering from a viral infection, the immune system makes antibodies—also called immunoglobulins—that are specific to the virus. They neutralize the virus and help clear it out; that's part of the mechanism of why you get better," Dr. Goldstein explained.

One way to see if a person has had Covid is to test for antibodies. "A positive test means you've been exposed to the virus because, in the absence of a vaccine, that's the only way you would have the antibodies. While it's not 100% certain that antibodies neutralize the virus, based on experience with other coronaviruses, it is likely," Dr. Goldstein said. Having the virus neutralized should offer at least some protection against future re-infections.

People who have had positive virus tests know that they have Covid or had Covid and recovered, but many people are asymptomatic or may have had what felt like a light cold, and they want to know if they are at risk, or if they have some protection against the disease. "This is really important for frontline healthcare workers, people working 8-10 hours a day in intensive care or the emergency room with patients known to be very sick with Covid-19; even with protective equipment, they have significant exposure to the virus," Dr. Goldstein explained. "If someone has been through the disease and has natural antibodies, they can't infect someone else. What you want to know on an individual level is am I safe from infection and am I safe for other people."

Generally, antibody testing is a fairly common procedure, Dr. Goldstein explained. When you spin blood in a centrifuge, it separates into three parts: red blood cells, plasma and serum. Serum is where you find antibodies. "ELISA (enzyme-linked immunosorbent assay) is a standard test that looks for antibodies, but it is not specific enough for the Covid-19 virus."

The challenge is there are multiple coronaviruses. "Four different coronaviruses are responsible for the common cold, and then there are others like SARS and MERS. They all have the same sort of halo or corona of protein around the outside of it," Dr. Goldstein said. "They look like the old naval mines used in war. The whole family of coronaviruses look like that. The amino acid sequences of different coronaviruses are not identical but very similar; they share a lot of common structures. There are only really small differences and you can't really pick them up using the usual physical methods."

Studies have shown that up to 90% of individuals in Western countries have been exposed to one or more of the common cold coronaviruses and have antibodies against them. "They look very similar to the coronavirus causing Covid-19. So in Covid-19 antibody tests, the most important thing is it has to be highly specific for the Covid-19 antibodies and doesn't test positive when it identifies a common cold antibody. That is a false positive," said Dr. Goldstein. "It's actually much safer not to have a test that has a lot of false positives because you could base a behavioral decision on faulty information."

Dr. Goldstein cited an example. "If you are testing 1,000 people and there is a 90% prevalence for the cold virus, that means around 900 people have antibodies to the common cold. If the prevalence of the Covid-19 virus is 2%, roughly 20 of the 1,000 would have antibodies to the Covid-19 virus. Let's say the serology test has 95% specificity. That means five times out of 100, it will give a false positive, indicating the presence of Covid-19 antibodies when it is really picking up antibodies against the cold virus. What this means is 5% of 900, or 45 people, will test positive for Covid when they have not had it, and are making decisions based on incorrect information. The consequences of being wrong are dramatic and highlight the need for a very good, high-quality serological test."

How does this relate to Alzheimer's and other neurological diseases that are ProMIS' core competency? "In Alzheimer's, ALS, frontotemporal dementia, Parkinson's disease and other neurological disease, we've been able to use our proprietary, unique technology to identify sites on misfolded proteins that are driving these diseases. Our core technology is the capability to understand what's special about the bad proteins that are causing these diseases and then we can make antibodies highly selective against them. Our technology allows us to identify a region, an epitopes target, which is a series of four to six amino acids where the protein has misfolded. Not only do we know where this target site is located, importantly we also determine the shape (conformation) of this site. Proteins like amyloid and alpha synuclein and TDP 43 misfold and when these proteins misfold they become toxic, they kill neurons, resulting in disease," Dr. Goldstein explained.

ProMIS has transferred that thinking to the virus causing Covid-19. "The corona is composed of the spiky protein. Remember, we want to be able to distinguish between the coronavirus causing the common cold and the coronavirus causing Covid-19," Dr. Goldstein said. "If we can distinguish between the two, we can have an antibody test that's specific for Covid-19. We are looking at a region of the virus called the receptor binding domain, the RBD, that is part of the spike protein and how it attaches to cells. We have a core competency that allows us to identify sites, and not just the location of the sites, but the shape of the sites on complex protein molecules. That allows us then to use that knowledge to create either antibodies or to create serum tests, or even quite frankly, we can use those targets to create vaccines."

Using ProMIS' proprietary technology, the company has been able to "identify a site that we believe is only present on the Covid-19 virus and not on other coronaviruses. We are now initiating the synthesis of several different forms of that site; it's a small area," Dr. Goldstein stated. "That would then transfer to Dr. Hans Frykman's lab at University of British Columbia, a world-class serology lab. Then we will see if the targets we've identified are specific and selective antibodies against Covid-19."

When you test the serum of an individual, if they've been exposed to the virus and have the antibodies, "those antibodies should bind selectively and specifically to the target. So if the antibodies from the patient's serum are binding to the target site, we know it's a Covid-19 virus because that site is only visible in that shape on the Covid-19 virus and not the others. For the validation of our test, only in patients known to have had Covid-19 should we see binding of antibodies against Covid-19 to our target. The second validation is based on testing in serum from subjects known to have never been exposed to Covid-19 virus—such subjects have antibodies only from cold or other coronaviruses, and therefore the antibody test should be negative; there should be no binding. So we should only see binding in serum from a patient known to have recovered from COVID-19, and we should not see binding in serum from an individual known not to have been exposed to COVID-19," Dr. Goldstein explained.

"Our technology basically allows us to zero in with sniper-like precision on the structure of a protein and understand it, not only the structure overall but the shape of the regions on that protein and then that allows us to identify what is specific to that protein, in this case the spiky protein on the virus causing COVID-19," said Dr. Goldstein.

ProMIS expects to have initial results in June.

Disclosure:
1) Patrice Fusillo compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: ProMIS Neurosciences. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of ProMIS, a company mentioned in this article.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: PMN:TSX; ARFXF:OTCQB, )

Source: Streetwise Reports   05/06/2020

In a May 4 research note, H.C. Wainwright & Co. analyst Ed Arce reported that Arcturus Therapeutics Holdings Inc. (ARCT:NASDAQ) formed a partnership with Catalent Inc. (CTLT:NYSE), which "raises the profile of LUNAR-COV19 as a leading vaccine candidate."

Arce reviewed Catalent's contribution to the partnership. The global contract development and manufacturing organization is to manufacture Arcturus' messenger RNA (mRNA) LUNAR-COV19 for protection against SARS-CoV-2 to be used first for human clinical trials and potentially, eventually commercially.

As for timing, Arce noted, San Diego, Calif.-based Arcturus intends to transfer its vaccine technology to Catalent this month and expects Catalent to manufacture the first batches of LUNAR-COV19 by June 2020. "Critically, Arcturus continues to anticipate initiation of Phase 1 testing of LUNAR-COV19 in the summer of 2020," Arce highlighted.

Catalent is to produce the vaccine at its biomanufacturing facility in Madison, Wisc. "This facility utilizes Catalent's flex-suite, a current good manufacturing practice manufacturing suite, that can produce batches at multiple scales and support Arcturus' proprietary mRNA manufacturing process," explained Arce.

Obtaining the vaccine from one facility domestically versus multiple entities worldwide should result in several benefits, Arce continued. They include easy development and production, accelerated delivery and improved costs. Arcturus believes Catalent can produce millions of doses of LUNAR-COV19 mRNA in 2020 and, if need be, hundreds of millions of doses each year subsequently for use globally.

Arce pointed out that LUNAR-COV19 differentiates itself from other similar vaccine candidates in that the technology and delivery platform behind it deliver an "extraordinarily low dose (perhaps 2 micrograms)" in "a potential single shot."

H.C. Wainwright has a Buy rating and a $62 per share price target on Arcturus, the stock of which is currently trading at about $42.12 per share.

Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures from H.C. Wainwright & Co., Arcturus Therapeutics Holdings Inc., First Take, May 4, 2020

Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.

I, Ed Arce, certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst's household has a financial interest in the securities of Arcturus Therapeutics Holdings Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of April 30, 2020 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Arcturus Therapeutics Holdings Inc.

Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The firm or its affiliates received compensation from Arcturus Therapeutics Holdings Inc. for non-investment banking services in the previous 12 months.

The Firm or its affiliates did receive compensation from Arcturus Therapeutics Holdings Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Arcturus Therapeutics Holdings Inc. during the past 12 months.

The Firm does not make a market in Arcturus Therapeutics Holdings Inc. as of the date of this research report.

H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.

( Companies Mentioned: ARCT:NASDAQ, )

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