“Criminal per SEC standards” is a serious claim. If that’s the case, cite the specific statute or violation.
Preparing manufacturing capacity ahead of clinical completion isn’t illegal — it’s operational planning. Validation timelines and equipment lead times don’t start after approval.
If there are factual inaccuracies in the PR, identify them specifically. Otherwise this sounds more like opinion than evidence.
That’s not “cart before the horse.” That’s sequencing.
Second — no one is “putting Radiogel into human bodies without FDA approval.” IDE approval is required before U.S. trials begin. Manufacturing preparation does not equal human use.
Third — throwing around “criminal per SEC standards” is reckless. If there were securities fraud:
• There would be an SEC investigation • There would be enforcement action • There would be trading suspension
None of that exists.
Capital expenditures and facility planning are disclosed in filings. That’s transparency — not deception.
Scams avoid operational investment. They don’t build infrastructure.
You can argue about timing. You can argue about dilution. You can argue about management style.
But calling basic biotech operational prep “criminal” just exposes a lack of understanding of how regulated medical manufacturing works.
When outrage replaces logic, the argument is already over.
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