Then instead of FDA notifying MSB that Clinical Data Sufficient for Refiling aGVHD BLA they could have said "Do not refile, this is not the data we are looking for".
I mean you treat users here like they are stupid but the tenacity of you suggesting the FDA would not have the balls to tell MSB where to put their data if it was insufficient is another level of absurd.
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-486
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