One simple question I have that relates to MSB and the last CRL on Paeds aGVHD
I know MSB have said they will supply more data on potency assay for Paeds AGVHD but have the FDA said they want it and will approve based on that data?
I know MSB have said that is their plan but have the FDA asked for it and endorsed that as a viable plan to be enough for the faster approval? Or has the FDA just saying do the adult trial to prove out aGVHD in totality.
Simple question as I don’t want us all to assume MSB’s more data for Paeds aGVHD fast plan is an endorsed path by the FDA. Since we can’t see the CRL.
Ann: Trading Halt, page-627
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