@Berger and @col69, both of you explained this very well.
But, just to simply this.
My view remains the same.
There's too many things stacked up well for this trial that the FDA will find it hard to deny:
- Pandemic (huge numbers of patients)
- Political pressure
- RCT
- NIH, NHLBI and CSTN are involved in this trial and not just Mesoblast
- ...
If the science stacks up - Mesoblast will be approved for Covid-19 ARDS under The Emergency Use Authorization (EUA) = expedited approval that Mesoblast has mentioned several times.
Bring it on!
Ann: Phase 3 Trial in COVID-19 ARDS Surpasses 50% Enrollment, page-229
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