some would argue that we have a solid chance of approval (albeit nothing is certain), after the FDA said that the data they already have in hand appears to be sufficient to address the concerns of the most recent CRL.
the CRL outlined what the FDA requires before approval, and now the FDA say they think they had what they needed all along.
it’s a very strange thing for the FDA to do a backflip, and they wouldn’t do so unless they were pretty sure they had no other choice. Whatever MSB provided in that type C meeting had to be extremely convincing.
The path of least resistance was to simply say to MSB, “continue as planned, run that adult trial and resubmit”… MSB were all geared up for that… so something quite profound has happened since that has resulted in such a dramatic backflip.
interesting times indeed…
goodluck all
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-843
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