We also know that mutated viruses can sometimes interfere with unumutated ones through a process called "lethal defection." Here these mutated viruses run interference and gum up the replication machinery. This limits replication of sub-lethally mutated viruss. (17/x)
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FDA presumably could ask for more data (especially since the efficacy in the second half seems so weird—zero benefit?) before approving rather than plunge into tail risk (as you note: theoretical, of course, not studied enough) since it's about more than individual patients. 2/2
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Maybe I'm overly naive, but the FDA will do what FDA always does...look at the data, consider input of their advisory panel and their internal experts, and make a decision. If approved, hospitals and physician groups will make guidelines about when to use it and how.
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Problem is FDA isn't tasked with thinking about effects of viral mutations beyond those people taking it. FDA might think people taking it will benefit* more than they are harmed, so approve. *but by just 30% in avoiding the hospital, which is just ~3% of the indicated pt pool.
End of conversation
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