By the way... When I look at the new guidelines in this way, it confirms, for me, my assumptions... The FDA will increasingly allow drugs that have not reached a PE. Why? Many recognize (unfortunately somewhat late) that a therapy is at least as important as a vaccine. Now, for example, we have a drug A and a drug B, each with different approaches, both of which would have missed their primary endpoint (e.B, mortality)... however, each one has an effect in itself and possibly drug A+B prevents death.... why not allow them for this very use? My opinion: a missed PE (which I do not accept for LL) will not mean at the same time, no approval in the future. (has happened some times in the meantime, if I am not mistaken...)