I’m not suggesting anything about a BLA submission by NWBO, but generally speaking, AI does not agree with what you said about SEC rules:
No, it is not illegal for a drug development company to keep the timing or status of a BLA (Biologics License Application) submission confidential.
• FDA confidentiality rules: The FDA does not publicly disclose submissions until an action (acceptance, review, approval, CRL, etc.) is announced. The company has discretion over when (or if) it tells the public.
• Securities law obligations: A publicly traded company must disclose material events that a reasonable investor would consider important for investment decisions. But the timing of disclosure is flexible: if management decides that a BLA submission isn’t yet “material,” or that premature disclosure could mislead without context, they can withhold it until a formal regulatory milestone occurs.
• Common practice: Many biotech firms keep submissions quiet until FDA confirms acceptance for review (the “Day 60 letter”), since acceptance is the point when the review clock officially starts.
Illegality comes in only if: • The company makes false or misleading public statements (e.g., saying they submitted when they didn’t).
• The company withholds submission info while insiders trade stock based on that non-public knowledge (insider trading).
Ex, I agree with you. The only reason a company wouldn't announce a PDUFA date would be if they're restricted from doing so. I don't know if an Orbis based filing would have such a restriction.
I do believe that being under Orbis is supposed to be handled in a secretive way, I'm not aware of any product that's been approved utilizing it yet. Does anyone know of a product approved multi-nationally through Orbis.
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