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Can a Form Letter from FDA "Blow Your Mind"?

Adam Feuerstein appears to be a generally astute observer of the biotech scene. As a finance writer, he's accosted daily with egregiously hyped claims from small drug companies and their investors, and I think he tends to do an excellent job of spotting cases where breathless excitement is unaccompanied by substantive information.


However, Feuerstein's healthy skepticism seems to have abandoned him last year in the case of a biotech called Sarepta Therapeutics, who released some highly promising - but also incredibly limited - data on their treatment for Duchenne muscular dystrophy. After a disappointing interaction with the FDA, Sarepta's stock dropped, and Feuerstein appeared to realize that he'd lost some objectivity on the topic.


However, with the new year comes new optimism, and Feuerstein seems to be back to squinting hard at tea leaves - this time in the case of a form letter from the FDA.


He claims that the contents of the letter will "blow your mind". To him, the key passage is:


We understand that you feel that eteplirsen is highly effective, and may be confused by what you have read or heard about FDA's actions on eteplirsen. Unfortunately, the information reported in the press or discussed in blogs does not necessarily reflect FDA's position. FDA has reached no conclusions about the possibility of using accelerated approval for any new drug for the treatment of Duchenne muscular dystrophy, and for eteplirsen in particular.


Feuerstein appears to think that the fact that FDA "has reached no conclusions" may mean that it may be "changing its mind". To which he adds: "Wow!"
Adam Feuerstein: This time,
too much froth, not enough coffee?


I'm not sure why he thinks that. As far as I can tell, the FDA will never reach a conclusion like this before its gone through the actual review process. After all, if FDA already knows the answer before the full review, what would the point of the review even be? It would seem a tremendous waste of agency resources. Not to mention how non-level the playing field would be if some companies were given early yes/no decisions while others had to go through a full review.


It seems fair to ask: is this a substantive change by FDA review teams, or would it be their standard response to any speculation about whether and how they would approve or reject a new drug submission? Can Feuerstein point to other cases where FDA has given a definitive yes or no on an application before the application was ever filed? I suspect not, but am open to seeing examples.


A more plausible theory for this letter is that the FDA is attempting a bit of damage control. It is not permitted to share anything specific it said or wrote to Sarepta about the drug, and has come under some serious criticism for “rejecting” Sarepta’s Accelerated Approval submission. The agency has been sensitive to the DMD community, even going so far as to have Janet Woodcock and Bob Temple meet with DMD parents and advocates last February. Sarepta has effectively positioned FDA as the reason for it’s delay in approval, but no letters have actually been published, so the conversation has been a bit one-sided. This letter appears to be an attempt at balancing perspectives a bit, although the FDA is still hamstrung by its restriction on relating any specific communications.

Ultimately, this is a form letter that contains no new information: FDA has reached no conclusions because FDA is not permitted to reach conclusions until it has completed a fair and thorough review, which won't happen until the drug is actually submitted for approval.

We talk about "transparency" in terms of releasing clinical trials data, but to me there is a great case to be made for increase regulatory transparency. The benefits to routine publication of most FDA correspondence and meeting results (including such things as Complete Response letters, explaining FDA's thinking when it rejects new applications) would actually go a long way towards improving public understanding of the drug review and approval process.




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DeepMind открыл код AlphaFold 3, AI-системы моделирования структуры белков

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IPL auctions will linger in the back of players' mind during India-SA T20Is, says Uthappa

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Phrenitis and the Pathology of the Mind in Western Medical Thought : (Fifth Century BCE to Twentieth Century CE) [Electronic book] / Chiara Thumiger.

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New York, NY ; London : Routledge, 2018.




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The Ecology of Biotic Interactions in Echinoids : Modern Insights into Ancient Interactions [Electronic book] / Elizabeth Petsios, Lyndsey Farrar, Shamindri Tennakoon, Fatemah Jamal, Roger W. Portell, Michał Kowalewski, Carrie L. Tyler.

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Mind over matter : hard-won battles on the road to hope / Jordin Tootoo with Stephen Brunt

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Why I Won't Mind Campaigning For Kangana

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Mind your own.... EYES




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How Google's DeepMind is Using AI to Tackle Climate Change

AI is often seen as a magical fix-all. It's not, but it is, says Sims Witherspoon, a powerful tool for unlocking communities' problem-solving capacities. Witherspoon is a program manager at Google's DeepMind, which made headlines when it reduced energy required to cool Google Data Centres by 40 per cent. Energy consumption is one of the problems AI can be used for, and DeepMind is working on it. ABOUT WIRED SMARTER Experts and business leaders from the worlds of Energy, Money and Retail gathered at Kings Place, London, for WIRED Smarter on October 9, 2018. Discover some of the fascinating insights from speakers here: http://wired.uk/V29vMg ABOUT WIRED EVENTS WIRED events shine a spotlight on the innovators, inventors and entrepreneurs who are changing our world for the better. Explore this channel for videos showing on-stage talks, behind-the-scenes action, exclusive interviews and performances from our roster of events. Join us as we uncover the most relevant, up-and-coming trends and meet the people building the future. ABOUT WIRED WIRED brings you the future as it happens - the people, the trends, the big ideas that will change our lives. An award-winning printed monthly and online publication. WIRED is an agenda-setting magazine offering brain food on a wide range of topics, from science, technology and business to pop-culture and politics. CONNECT WITH WIRED Web: http://po.st/WiredVideo Twitter: http://po.st/TwitterWired Facebook: http://po.st/FacebookWired Google+: http://po.st/GoogleWired Instagram: http://po.st/InstagramWired Magazine: http://po.st/MagazineWired Newsletter: http://po.st/NewslettersWired




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Deepmind, Co-founder and CEO, Demis Hassabis discusses how we can avoid bias being built into AI systems and what's next for DeepMind, including the future of protein folding, at WIRED Live 2020. "If we build it right, AI systems could be less biased than we are."




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Aphantasia: The People Without a Mind's Eye | 'Out of Mind' | Wired UK

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Rohini Nilekani Centre for Brain and Mind launched at NCBS Bengaluru

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The technological innovation process is acknowledged as a sequence of procedures that engineers follow to find the best solution to a problem. That allows designers to use math concepts, applied research and technological innovation sciences to obtain a high level of optimization that meets the requirements of an goal. The steps incorporate defining the situation, […]