Regard this announcement as final acknowledgement from FDA regarding overwhelming approval from OCAD (hopefully got that right, the one that voted 9/10 regarding product approval, and from memory the only member not to vote for it had a conflict of interest) where the FDA required more info, or am I barking up the wrong tree here. Another step forward however you look at it imo.
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-149
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