The CIA from the very first days of the Trump administration, even before he was inaugurated, devoted themselves to sabotaging the administration because Donald Trump questioned just a few of their pieties. And that can't be done in Washington. Whoever does that must be destroyed. And so the CIA and the Deep State operatives became heroes of the liberal left, the people who support the Democratic party. They're now in a full union with the neocons, the Bush Cheney operatives, the CIA, Silicon Valley, and Wall Street. That is the union of power along with mainstream media outlets that are fully behind the Democratic party, which is likely to at least take over one branch of government, if not all of them, with the coming election, and that is a very alarming proposition because they're authoritarian, they believe in censorship, and they believe in suppression of information that exposes them in any kind of a critical light. Continue reading →

The $20 Secret Santa limit applies to everyone except your friends who work in finance. Wall Street bankers are about to cash substantially bigger bonus checks at the end of this year, according to a report released yesterday by Johnson Associates. Coming after two consecutive years of lower…

Asia-Pacific stock markets were trading mostly lower Wednesday, tracking losses on Wall Street as the U.S. post election rally stalled overnight. Asian traders assessed corporate goods data out of Japan, which showed year-on-year producer price growth, or wholesale inflation, in October reached…

Suspicious Activity Detected Activity violating our Terms of Use has been detected on your TipRanks account. Such activity could comprise of any of the following: Exceeding 80 page views of a specific page type within a 24 hour period. Utilizing bots, crawlers or other scraping tools. In most…

Officials are still investigating the cause of the blast, which damaged homes and vehicles.

Taylor Swift is known for her glamorous red-carpet looks and sparkling stage outfits. But she's also fashionable in her everyday life.

Snowball the cockatoo bobs his head and lifts his leg to the beats of the Backstreet Boys' "Everbody"

Artist Michael Kirby spent four days painting an image from "Falnama: The Book of Omens" in front of the Arthur M. Sackler Gallery. Read more at: https://www.smithsonianmag.com/smithsonian-institution/muralist-uses-the-sidewalk-outside-the-sackler-gallery-as-canvas-20678724/

The city famous for blues and barbecue is a little “ragged around the edges” according to tour guide Tad Pierson, who drives tourists around in his pink 1955 Cadillac by Lucian Perkins

Steve Lazarides' personal collection of prints, original works, handwritten press releases and burner phones sold at auction for around $1.4 million

These images from the Smithsonian Magazine Photo Contest capture quintessentially Cuban scenes

Pedestrians in Montreal, Grand Rapids and other locations can time-travel thanks to installations that map historical scenes directly onto the cityscapes

Tammy Roberts, Home Base's executive director, said before these services launched, there was "no place for youth to go" other than the emergency room or to RCMP cells. 

Service Team members share why they enjoy being onsite during Setup Week, when the vision of TeenStreet becomes a reality for them, and what part of the upcoming conference they are most excited for.

How do you encapsulate everything that goes into a full week of teaching, worship music, workshops, meals and so much more? Enjoy a brief overview of TeenStreet 2019.

Can young people be united in faith, irrespective of their ethnic background? The answer is yes!

An OMer in Hungary shares how God intervened in the lives of women in the sex industry through the Bus4Life ministry

OM workers minister to drug addicts and women in prostitution on a Tel Aviv street.

God changes teens' lives during TeenStreet Queensland in Australia at the beginning of July.

Teens in Europe are gathered this week to connect with Jesus and each other. A month ago, teenagers in Australia had this experience.

A group of Bulgarian teenagers and leaders took part in this year’s TeenStreet Europe for the first time and experienced God in new ways.

Penn State Centre Stage will produce Stephen Sondheim's "Sweeney Todd: The Demon Barber of Fleet Street,” with book and lyrics by Hugh Wheeler, music directed by Anne Van Steenwinkel, Nov. 12–22, at the Playhouse Theatre on the University Park campus.

Many executives have reservations about backing either candidate in the US presidential election.

Nov 6 - With Donald Trump heading back to the White House, Wall Street is anticipating the potential for lower taxes, deregulation and a U.S. president who is quick to sound off on everything from the stock market to the dollar. Trump made tariffs a

Brian Black’s newest book, “Ike’s Road Trip: How Eisenhower’s 1919 Convoy Paved the Way for the Roads We Travel,” has received a full review by Mark Yost for the Wall Street Journal.

French teens attend TeenStreet 2012 and help raise money for youth ministry in Bosnia-Herzegovina.

A church youth group sees God provide finances for the teens to attend TeenStreet Europe 2013 in Germany.

A student with OM Chile’s Intensive Mission Training and a man living on the streets of Santiago dream together about what heaven will be like.

Azamat was living in the streets, but through the ministry of OM team members in Central Asia he moved into rehabilitation and then seminary.

A simple shelter in Central Asia provides a place for homeless women to get off the streets and connect with God.

Teens learn about the REAL Jesus of the Bible and how to have a REAL relationship with Him at TeenStreet 2011 in Offenburg, Germany.

Leader of OM Germany serves in the kitchen during TeenStreet, OM’s annual week-long international youth congress that started on Saturday.

TeenStreet 2015 encouraged thousands of participants from around the world to be HOME with God, experiencing His presence in their daily lives.

During TeenStreet 2016 a group of 29 people went to a refugee camp in Oldenburg, Germany to share the love of Christ.

Summary of TeenStreet 2016 in Oldenburg, Germany

How does TeenStreet, a 25-year-old ministry to youth, fit into OM's new global mission focus?

Apple Chaat is the perfect fusion of street food culture and healthy eating. With its vibrant flavours and nutritious ingredients, it's a great way to enjoy apples in a whole new light.

The 7th Street Boating and Fishing Area on the Christina River has officially reopened to Wilmington's Eastside community, with DNREC, in partnership with the city, celebrating the $2.9 million project with a ribbon-cutting ceremony in John Barbiarz Park, where the popular facility is located.

Dutch police disperse people from streets after Amsterdam tram set on fire

Margot Robbie uses the ultimate emotionally packed movie to cry in movies, and that’s what she did in the Wolf of Wall Street.In a yet-to-be-released episode of the Talking Pictures: A Movie Memories Podcast, which premiers on Nov. 26, the actress was recently questioned how she...

Wall Street firms are expected to pay heftier bonuses for this year, the first increase since a bumper year in 2021, according to a report by compensation consultancy Johnson Associates. Payouts will probably rise after financiers benefited from several factors in recent months: a recovery in dealmaking, the Federal Reserve cutting interest rates and equity […]

to wire your street rod

AI and Google Street View have created 'digital twins' of living trees in North American cities – part of a huge simulation that could help make urban tree planting and trimming decisions

The flats are described as the first new homes on the Scottish town's High Street 'in living memory'

Sega are delisting several bundles of 'classic' games from digital stores, along with "select individual" games. On Steam specifically, this adds up to over 60 games in total, including several actual classics including the original Streets Of Rage trilogy, Crazy Taxi, and Jet Set Radio.

The games will be removed on December 6th but will remain playable to those who already own them.

Read more

AI and Google Street View have created 'digital twins' of living trees in North American cities – part of a huge simulation that could help make urban tree planting and trimming decisions

It is a surprisingly common peril among analysts: we don’t have the data to answer the question we’re interested in, so we answer a related question where we do have data. Unfortunately, the new answer turns out to shed no light on the original interesting question.

This is sometimes referred to as the Streetlight Effect – a phenomenon aptly illustrated by Mutt and Jeff over half a century ago:

This is the situation that the Tufts Center for the Study of Drug Development seems to have gotten itself into in its latest "Impact Report".  It’s worth walking through the process of how an interesting question ends up in an uninteresting answer.

So, here’s an interesting question:

My company owns a drug that may be approvable through FDA’s 505(b)(2) pathway. What is the estimated time and cost difference between pursuing 505(b)(2) approval and conventional approval?

That’s "interesting", I suppose I should add, for a certain subset of folks working in drug development and commercialization. It’s only interesting to that peculiar niche, but for those people I suspect it’s extremely interesting - because it is a real situation that a drug company may find itself in, and there are concrete consequences to the decision.

Unfortunately, this is also a really difficult question to answer. As phrased, you'd almost need a randomized trial to answer it. Let’s create a version which is less interesting but easier to answer:

What are the overall development time and cost differences between drugs seeking approval via 505(b)(2) and conventional pathways?

This is much easier to answer, as pharmaceutical companies could look back on development times and costs of all their compounds, and directly compare the different types. It is, however, a much less useful question. Many new drugs are simply not eligible for 505(b)(2) approval. If those drugs

Extreme qualitative differences of 505(b)(2) drugs. Source: Thomson Reuters analysis via RAPS

are substantially different in any way (riskier, more novel, etc.), then they will change the comparison in highly non-useful ways. In fact, in 2014, only 1 drug classified as a New Molecular Entity (NME) went through 505(b)(2) approval, versus 32 that went through conventional approval. And in fact, there are many qualities that set 505(b)(2) drugs apart.

So we’re likely to get a lot of confounding factors in our comparison, and it’s unclear how the answer would (or should) guide us if we were truly trying to decide which route to take for a particular new drug. It might help us if we were trying to evaluate a large-scale shift to prioritizing 505(b)(2) eligible drugs, however.

Unfortunately, even this question is apparently too difficult to answer. Instead, the Tufts CSDD chose to ask and answer yet another variant:

What is the difference in time that it takes the FDA for its internal review process between 505(b)(2) and conventionally-approved drugs?

This question has the supreme virtue of being answerable. In fact, I believe that all of the data you’d need is contained within the approval letter that FDA posts publishes for each new approved drug.

But at the same time, it isn’t a particularly interesting question anymore. The promise of the 505(b)(2) pathway is that it should reduce total development time and cost, but on both those dimensions, the report appears to fall flat.

• Cost: This analysis says nothing about reduced costs – those savings would mostly come in the form of fewer clinical trials, and this focuses entirely on the FDA review process.
• Time: FDA review and approval is only a fraction of a drug’s journey from patent to market. In fact, it often takes up less than 10% of the time from initial IND to approval. So any differences in approval times will likely easily be overshadowed by differences in time spent in development. 

But even more fundamentally, the problem here is that this study gives the appearance of providing an answer to our original question, but in fact is entirely uninformative in this regard. The accompanying press release states:

The 505(b)(2) approval pathway for new drug applications in the United States, aimed at avoiding unnecessary duplication of studies performed on a previously approved drug, has not led to shorter approval times.

This is more than a bit misleading. The 505(b)(2) statute does not in any way address approval timelines – that’s not it’s intent. So showing that it hasn’t led to shorter approval times is less of an insight than it is a natural consequence of the law as written.

Most importantly, showing that 505(b)(2) drugs had a longer average approval time than conventionally-approved drugs in no way should be interpreted as adding any evidence to the idea that those drugs were slowed down by the 505(b)(2) process itself. Because 505(b)(2) drugs are qualitatively different from other new molecules, this study can’t claim that they would have been developed faster had their owners initially chosen to go the route of conventional approval. In fact, such a decision might have resulted in both increased time in trials and increased approval time.

This study simply is not designed to provide an answer to the truly interesting underlying question.

[Disclosure: the above review is based entirely on a CSDD press release and summary page. The actual report costs $125, which is well in excess of this blog’s expense limit. It is entirely possible that the report itself contains more-informative insights, and I’ll happily update that post if that should come to my attention.]

The New Wall Street & Technology