I understand in normal circumstances p values etc

I understand in normal circumstances p values etc but I am looking at a different standard of approval which is “ what was the bar for approval for Remdisivir”. It was based on a reduced time in the hospital and a very minor improvement on death rates. The FDA will have a very hard time changing the rules of the game after lowering the bar for Remdisivir if they reject LL..they have put themselves in a tough situation both to the public and politically