If the FDA are saying that the lack of Potency Assy supplied for Ryoncil used during the Phase three trial for SRGVHD would not support an Adequate study, is that not saying that based on the data supplied, from the FDA's perspective, unless proved otherwise, it failed in regard to potency which intern cannot ensure efficacy from one patient to the next?
Ann: Mesoblast Type A Meeting with FDA, page-41
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