"in the 7th of March 2024 - potency assays was what they were going to the FDA about."
And then after that meeting, we get the announcement about "appears sufficient."Have you considered that"remaining product charactisation issues" 27 March 2024 -
might just mean the resubmission will include the data on all the product characterization issues that remained after CRL2, consolidating all the data they presented to and discussed with FDA prior to FDA's communication about how the available clinical data "appears sufficient?"
After being twice burned, do you really think MSB would refile this quarter if they thought there were "remaining product characterization issues" that hadn't been resolved to the FDA's satisfaction?
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- Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-956
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