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Biotech / Medical : ImmunityBio converts from Immunomedics
IBRX 2.110-1.4%Nov 6 3:59 PM EST
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To: jargonweary who wrote (987)5/5/2025 11:33:32 AM
From: TinfoilHat3 Recommendations

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bobbseytwins2001
erippetoe
urslor

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My thoughts exactly too, and also FML for having posted ra ra support just days before.

Based on how the PR is worded my assumption is this is not a clerical error rather reinforcing the position from I think late 2023 where they were asked to run a confirmatory trial.

Seems this past Jan they shared updated longer term data and were encouraged to submit.

I'm not a regulatory expert but it could be they didn't follow formal process, misinterpreted positive feedback about the papillary data in a meeting that wasn't about the papillary data and got encouraging responses, however would have needed to schedule another Type B or Type C meeting with FDA (someone who knows more please chime in) specific to papillary to reconfirm no more need for a confirmatory trial.

Best case scenario is whomever processed the sBLA did not get the memo that IBRX already got green light in that Jan meeting to proceed.

All I know is short selling interest rate is pretty low right now, and short as a percent of float is nearing 60% now, up from 49% in Jan. Shorts are usually right, FML for not following this more closely but I have learned that I suck at trading and never time things anyways so prefer to just keep buying to cost-avg down when there is blood in the streets. Not advice to anyone, but sharing in case helpful. The good thing about IMMU is that I am now numb to intra day pain and stock volatility.

Hope someone with Regulatory knowledge can help parse the tea leaves, whether a company snafu or a possible FDA staffing oversight.
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