I read that as the FDA accepted the potency assay that has been developed but there are gaps in the data that now need to be backfilled? not sure if I'm reading it incorrectly and makes no sense that the data wouldn't have been generated due the resubmission?
imo they should go the whole way and test samples all the way back to the older failed trial with different manufacturing process (if they haven't already)
Ann: Mesoblast Type A Meeting with FDA, page-17
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