Potency assays and CMC approvals important for other studies to be approved to commence - A thought occurred to me about the importance of the potency assays and the CMC approvals and that is that approval of the assays and CMC issues being resolved was a pre-requisite for the commencement of other studies. From recollection ARDS and CLBP. Regardless of whether this constitutes a resubmission, acceptance of the assays and the CMC fixes is critically important to moving forward.
Ann: Submits New Information to FDA IND File for SR-aGVHD, page-294
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