Nicholas Schiefer on Twitter: "@voretaq7 I have to ask: what is that takes the FDA a hard 20-60 days to review even if they were in a hurry? Like, I can read a page an hour even from a dense math book. At a societal level it would be worth having a very large staff on-hand to review it quickly, I think?" / Twitter

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Oh, so we disagree less than I thought! My preferred regulatory regime would indeed create finer grained distinctions and rely more on individuals and their doctors to make treatment decisions.

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I think that's consistent with the overall regulatory posture. Tens of thousands of vaccinated people will probably die from Delta, but the FDA thinks that those deaths are worth the conservatism on EUAs, I think?

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Almost certainly is, like, a 1 in 1,000 hazard ratio, right? If that's the case, there will definitely be hundreds to thousands of Delta deaths in vaccinated people in the US alone, if my math is right. And separately, there's a lot of harm that I care about other than death.

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Nicholas Schiefer

@nschiefer

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@voretaq7

I have to ask: what is that takes the FDA a hard 20-60 days to review even if they were in a hurry? Like, I can read a page an hour even from a dense math book. At a societal level it would be worth having a very large staff on-hand to review it quickly, I think?

11:18 PM · Aug 11, 2021Twitter Web App

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I understand that they're complex, which is why I compared it to ~the most complex documents I know of. 😉 I do strongly suspect that it is *physically possible* for the FDA to get through this in a few days or so, given sufficient preparation? The stakes are quite large.

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