@JB1975 and DocMcStuffins - MSB have been very clear that the potency data provided was additional analysis of the data coming from the successful phase III trial in relation to a potency assay that was used (in addition to the one submitted with the results) but not submitted. Given that the potency assay was the key element preventing the trial as being considered as 'adequate and sufficient' it is clear the FDA is saying there is enough here for us now to consider the assay and use the successful trial to consider approval.
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-120
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