One thing that you said, Phaedrus, about the ODAC “practise” experts reminded me of something I’ve always wanted to say about this company. It’s headed by very experienced medical practitioners rather than just biomedical experts.
Drug applications often get assessed by people at the FDA with their PhDs but who can lack a real world perspective. I think it explains why the FDA sometimes has difficulty explaining what they want.
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Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-798
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