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Re: nelskof post# 26419

Wednesday, 10/14/2020 9:08:22 AM

Wednesday, October 14, 2020 9:08:22 AM

Post# of 44695
I'm not gonna try to get into the FDA's head, but "safe and may be effective" seems like an especially low hurdle. As I understand it, the bigger the gap in efficacy between the treatment arm and SOC, the smaller the sample size needed. And there's a BIG gap between 80% and 17%. Not to mention, patients were followed for 60 days, which seems to be FDA's preference (at least with vaccine trials).