The FDA approval process for covid treatment will be very different than for GVHD. If they do pull off a result in the trial, this trial basically addresses everything the FDA were concerned about for GVHD plus there'll be added political pressure to get treatments out for the public to access.
The Covid trial is more "FDA friendly" than GVHD because it has:
- been codesigned with the FDA to their specifications
- is a full RCT
- is powered above and beyond what was thought to be necessary
- has secondary objectives to assess biomarkers for inflammation
If it achieves a significant result, it satisfies all the objections from GVHD and should be approved. Sure you can say that GVHD should have been approved as well, but the covid trial addresses all the gripes, so unless there are new gripes, then we'll be through the door.
The FDA may ask for a phase 4 trial for covid, depending on what else is approved by then... but I think that would be an acceptable trade-off.
Ann: Phase 3 Trial in COVID-19 ARDS Surpasses 50% Enrollment, page-350
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