Now I can't help but wonder..... If the ARDS results come back positive, what if the FDA reject it because we can't explain the potency assays and TNFR1 levels any more than we have allready done.....
Once it is approved for ARDS, it's available for everything off label so moree than likely no other trial will happen, and gvhd would start using it - that is not what the FDA wants.
If they don't approve it for COVID, then it cannot be used for GVHD?
Crazy I know.
MSB to dispute FDA finding in Type A meeting, page-127
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