“We thank the FDA for their active dialogue”…. You don’t have active dialogue and then somehow not meet their requirements… if it wasn’t going to be enough for them to accept the resubmission then mesoblast would already know
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- Ann: Mesoblast Completes Resubmission of BLA to FDA for SR-aGVHD
Ann: Mesoblast Completes Resubmission of BLA to FDA for SR-aGVHD, page-94
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