I think that presupposes that high-risk individuals are never going to come out of their homes and therefore the mortality rate will dictate an inferior P value. At the end of the day the entire point of the medicine is to allow all people to get out of their homes and start earning a living which will not happen for anyone over 40 if they are seriously worried about dying. Given that I think there is some wiggle room with regard to the FDA the government etc. with regard to approval especially when you take into account SAE… But if there ISNT we as Americans have much bigger problems I but like I said before I don’t believe in grassroots, petitioning, pressure on the FDA… If the fix is truly in then none of that will matter.