RE: Regulators16 May 2022 15:02
Prion, 2 things
1. It's exploratory, it becames unethical (p-hacking) to the point that it is used to mislead about the importance of it.
2. The point of my post is that they did not find a definitive benefit with the post hoc analysis. They found another signal, perhaps a better one this time but that is subject to a clinical trial where those populations are pre defined. If it was p value of 0.001 then maybe they would get an eua (but still subject to getting the actual trial going).