Ann: Phase 3 Trial in COVID-19 ARDS Surpasses 50% Enrollment, page-164

I find it impossible to believe that the efficacy would be so narrow in the potential patient population... But yes ultimately we are trying to prove a broad spectrum treatment NOT game the approval process... Hopefully the treatment is working, we get to approval sooner rather than later and this can be sorted out in a Phase 4 if necessary...

There seem to be a lot of people arguing against an agile expedited approval because of their desire for statistics etc. They either don't understand the 10,000 to 100,000's of extra deaths the ongoing delays are causing or think that that is an acceptable trade off...

We have 10 years of safety data, some flexibility on efficacy is warranted in the current circumstances. STATISTICS, RCT's, The accreted FDA processes and procedures etc are just tools they are not the GOAL.

The next problem is manufacturing scale up/out and again it doesn't really seem to being worked on in a serious way...