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Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-306

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    Only line in the announcement potentially relating to potency assays is the last bit in my opinion - "...seeking to address all remaining product characterization issues".

    Potency assay stuff is product characterization stuff - so that could be an acknowledgement (in an obscure general way - that they don't have an all clear on potency assay approach) but as I said "product characterization" is a broader term. It could pick up screening product for viral contamination etc and a bunch of other stuff unrelated to potency assays (as specific metrics intended to track product potency).
 
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