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Biotech / Medical : ImmunityBio converts from Immunomedics
IBRX 2.065-2.1%9:49 AM EST
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To: Fitzhughlaw who wrote (990)5/6/2025 10:06:29 AM
From: Fitzhughlaw4 Recommendations  Read Replies (2) of 1229
 
So upon further review of the company's PR, I need to amend my prior absolution of Adcock, because this could indeed be another screw-up. Note these separate portions:

"This RTF letter was received despite reaching unanimous guidance and encouragement at the in-person January 2025 meeting from the leadership of the Agency, including from CBER, CDER and OCE to submit this sBLA." [emphasis supplied]

Now note this subsequent excerpt: "The Agency leaders present at the January meeting unambiguously invited the Company to expeditiously submit an sBLA for the NMIBC papillary indication... ." [emphasis supplied]

The first reference to "this" sBLA is arguably misleading because it implies that what was shown to and encouraged by the FDA is the same submission that was subsequently filed in March, and brought about the RTF, whereas the second excerpt that uses the words "an sBLA" demonstrates that such was not the case, and that the actual submission in March had not been the same document(s) shown during the January meeting. Whether what was shown in the January meeting was a draft, outline, or partial submission is not apparent, but the most likely inference from trying to reconcile the above two excerpts is that the actual submission in March was botched.

Fire Adcock.
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