Ann: Update on Scheduled FDA Advisory Committee Meeting, page-84

"Approved with a post-marketing observational study like Tecartus. (IMO) "

That's my base case after reading through the FDA notes. There is nothing new here which FDA did not know about before the rolling BLA process began. None of those issues could ever have been addressed post hoc and would have required new studies. The approval will just include additional manufacturing controls/inspection points which will be monitored to clinical outcomes in a Phase 4 study. All IMHO.

All very disconcerting, just the same when put in black and white by FDA. But this is their regulatory language and has obviously freaked out the market when ppl were sitting on huge profits. Not a good combo. LOL