NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

The key is if MHRA has actually made a decision. Per the law, the actual MHRA decision is after the CHM has had a chance to opine.

Your claim that NWBO has no obligation to disclose major regulatory objections from the MHRA is legally baseless. The difference between your argument and mine is that I cite binding precedent — you rely on "trust me bro" logic.

Once a company chooses to speak on a subject, it cannot omit material facts necessary to make those statements not misleading.

Basic Inc. v. Levinson, 485 U.S. 224 (1988)

On June 11, 2025, NWBO chose to speak about DCVax-L and the UK regulatory process in a public press release. The company explicitly stated that:

“The Company has completed a 331-patient Phase III trial of DCVax-L for GBM… and submitted a MAA for commercial approval in the UK. The MAA is currently undergoing review.”

If NWBO was, at the time of that statement, in possession of formal objections from the MHRA — or if the application had already been referred to the CHM for rejection — then this press release becomes materially misleading by omission. This is not debatable: once a company publicly affirms that a regulatory submission is "undergoing review," it must also disclose any material negative developments that would alter the total picture for investors. That is precisely what Rule 10b-5(b) prohibits: half-truths that mislead by failing to disclose material facts.

If NWBO knowingly omitted this kind of adverse regulatory development while continuing to promote its lead program in public filings or press communications, it would expose the company — and potentially its officers — to significant legal liability under U.S. securities law, including shareholder suits and SEC enforcement. So no — the idea that NWBO can legally stay silent about major MHRA objections while simultaneously touting its active MAA is not just wrong. It’s legally reckless.

By the way, SEC Rule 10b-5 is one of the most important SEC rules to protect investors. You either are very naive or misleading, not mentioning that.

The rule prohibits any act or omission resulting in fraud or deceit in connection with the purchase or sale of any security.