I think you guys are putting too much time into th
Post# of 153798
(Total Views: 452)
Posted On: 02/24/2021 5:13:46 PM
I think you guys are putting too much time into this 28-day/42-day discussion. Regardless of trial design, the FDA is going to look at both to try to find a survival benefit.
I'm as big a FDA conspiracy theorist as anyone here, but I think recent FDA guideline shifts indicate they are finally at a point where they need to find a successful survival therapeutic. Right now, they have nothing. From my perspective given the severe condition these patients are in, if I were a trial participant, I don't care if I live 28 or 42 or 60 days, I want to live well past that, and I think the FDA is now on board with that. I only hope they don't prove me wrong.
I'm as big a FDA conspiracy theorist as anyone here, but I think recent FDA guideline shifts indicate they are finally at a point where they need to find a successful survival therapeutic. Right now, they have nothing. From my perspective given the severe condition these patients are in, if I were a trial participant, I don't care if I live 28 or 42 or 60 days, I want to live well past that, and I think the FDA is now on board with that. I only hope they don't prove me wrong.
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