My understanding is for GVHD, MSB is scheduled to meet the FDA...

My understanding is for GVHD, MSB is scheduled to meet the FDA this month for two purposes:

• Pathway to approval for Pediatric
• Agreement on the design protocols for P3 for adult

Following on from that a few possible scenarios:

1. FDA accepts that the new potency assay data fulfils the CRL requirements. Then Mesoblast needs to resubmit the BLA. Then the FDA will determine the BLA classification and set a PDUFA date
2. FDA does not accept that the assay data fulfils the CRL requirements. Then Mesoblast needs to be clear and agree on what the AA pathway is for Ryoncil Pediatric. This one will definitely require minutes from this FDA meeting. What is that pathway - commencement of the adult trial? Surrogate end-points? What are the processes/ procedures to be done to get the AA - that's a bit murky atm as the efficacy question has already been determined i.e. ODAC 9-1 vote
3. FDA agrees/ disagrees on the design protocols for P3 for adult

Anyway, we'll find out all this soon - stay tuned!

GL MSB'ers - onwards and upwards