and now the FDA say they think they had what they needed all along.
In that case (pun intended), the CA lawyers must be in a panic (not that I ever thought they had a valid case in the first place) …. LMAO
I would rather the BLA resubmission is water tight this time around as I believe we will receive a 2 month PDUFA date so I am ok with it being lodged in late June
GLTAH
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-849
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