From listening to the podcast, if the Type A meeting is not approved, then I understand MSB intends to shut up shop on aGHVD. It could be postulating and early words, but I understand that there will be no more trials paid for by MSB. I don't mind this as it paints FDA into a corner, and makes them aware that their delay in going against ODAC etc is unprecedented and if they maintain their decision then children will die.
I understand the whole point of "what if the other 30% could have been saved", but that is what is a post-marketing trial is for. You do not let 100% die in the meantime.
@stockrock thanks for the analysis - I agree but differ slightly in confidence. FDA "recommended" a trial in "adults and/or children" - there is clearly ambiguity there, and it could be very reasonable that FDA predicted a Type A meeting would follow and in this meeting they will recommend a adult Phase 3 trial, but approve children in the meantime. Otherwise, it makes no sense to use the words "recommend" and the use of "and/or" - that allows flexibility, and it makes no sense to do a trial in adults to confirm efficacy in children IMO.
Overall, I am still confident in approval in "3-5 months" as that accords with what SI said and the timelines. However, we will know more in the next fortnight, particularly if FDA agree to a Type A meeting.
If not, there is still CLB, CHF, MIS-C, ARDS and Chrons - talk of things "getting messy" is off the mark with $100mil in the bank and a partnership agreement for CHF coming up.
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