I'm confused - "this will address OTAT's recommendation for an additional adequate and well-controlled study" - is that part of the original CRL or has OTAT raised this again during these recent meetings?
Also, does Mesoblast now have the data to remove the need for this additional trial?
@stockrock thoughts?
Arghhhh - why can't these Mesoblast announcement be more straight forward - just spell it out!
Ann: Update on FDA Meeting for Remestemcel-L in Paediatric GvHD, page-31
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