Monday morning, Mesoblast said that it added new information on an optimized potency assay to the IND file on the drug, setting the biotech up to resubmit its BLA in the near future.
Above from Endpoint News article
@pfeifer1982 - Person with the most certainty wins……
would you happen to know the turnaround time for a response from the FDA re the new evidence submitted?
Asking for 2500 friends
Reg
Ann: Submits New Information to FDA IND File for SR-aGVHD, page-278
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