Everyone seems to be ignoring the political consequences of NOT approving AGVHD at this point.
Without approval for AGVHD it's not a simple label extension for Covid-19 / ARDS in three weeks time. The political optics of recommending for Covid-19 / ARDS (admittedly from a very clear cut quad blinded phase3 trial) but requiring yet another trial for the sick children, is horrible.
Remember that the FDA can approve regardless of the AdCom result... The bodies are stacking up in the meantime.
[ Not that I think the AdCom result will be negative ]
Ann: Update on Scheduled FDA Advisory Committee Meeting, page-177
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