IIRC because the allogenic cells are, by definition, from someone else the RMAT rules as they were a while ago meant you had to have P3 results before approval to market would be considered.
Otherwise, so long as the cells and the treatement met other criteria, you could have just P2 and rely and on records from patient outcomes over a set period of time for final approval.
Even if the results are truly wonderful I can't see them changing the rules, not that quickly, maybe later on, down the track, but it would take a lot of consideration and effort. So far as I can see those rules trace back beyond this guidance document.
All that said the future still, to me, could be really good, but there are 2 more sleeps to be sure
IIRC because the allogenic cells are, by definition, from...
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