Cell Therapy News/Articles, page-5681

AGVHD approval (which is 99% certain) is likely to be overshadowed by the COVID ARDS interim results, which are due out in "early September." Assuming those are blockbuster, and with ~45 patients having received the full treatment--in a double-blind RCT against placebo, that should put to rest ANY lingering FDA concerns about efficacy (assuming they are inclined to ignore the AdComm on AGVHD). Agree they MAY order a Phase 4 just to save face, but tending to think it's unlikely, as MSB will be the Golden Child at that point.

And that dude Hinrichs is gonna feel like a real heel if the ARDS trial is a success, too. Not sure what was behind his vote, but he'll go down in history as the "guy who claimed that Rem-L, the cure for ARDS in COVID, was "not efficacious" against AGVHD. Way to go, Smedley...