NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

f the MHRA wants to reject, they must first refer it to a CHM meeting for review. Once that happens, and the CHM backs the MHRA's recommendation to reject, NWBO is then allowed to go through an appeal process which can take months if not years.

You are partially misstating this.

After a negative CHM opinion, the company has the right to make written and/or oral representations before a final refusal is issued. This is not called an "appeal" in legal terms, but rather a representation stage, akin to an internal review process. Regulation 126(5) of the HMR 2012:

“The applicant shall have the opportunity to make representations before a final decision is made by the licensing authority.”

There is no automatic appeal to an external court unless the refusal is formally issued and challenged via judicial review, which is rare and costly.

The CHM review and representation process can add several months, especially if the applicant requests oral hearings. In unusual or contested cases, the process could stretch longer but years is not typical unless the company delays or launches judicial review proceedings post-refusal. In practice, 3–9 months is a more grounded expectation between the start of CHM involvement and final MHRA decision (approval or refusal).

Only after the appeal process is complete and the CHM still recommends to reject does the MHRA actually have the authority to officially reject the application

MISSTATED. The MHRA already has the authority to issue a rejection after the CHM review and applicant's representations are complete.
The CHM does not "grant" that authority; it advises. The MHRA retains final decision-making power. So, MHRA doesn’t need the CHM to “still recommend to reject” at the end of the process to proceed. If the representations don't change the outcome, MHRA can finalize the refusal.

if NWBO were formally notified of a CHM-backed recommendation to reject their Marketing Authorisation Application (MAA) and did not disclose this to investors in a timely manner, it could indeed constitute a serious violation of U.S. securities laws, particularly SEC Rule 10b-5 under the Securities Exchange Act of 1934.

Rule 10b-5 (anti-fraud rule):

It is unlawful for any person... to make any untrue statement of a material fact or to omit to state a material fact necessary in order to make the statements made... not misleading... in connection with the purchase or sale of any security.
A material fact is anything a reasonable investor would consider important when making an investment decision.
A regulatory setback — such as an official notification that the MHRA is intending to reject an application (especially if endorsed by the CHM) — would absolutely be material to NWBO investors.
Silence in the face of material bad news can be just as actionable as making false statement

If NWBO: Withheld a known regulatory rejection trajectory;
Continued to issue promotional or forward-looking statements without disclosing that risk;
And investors suffered losses once the truth emerged...
Then: The company and its officers could be liable for securities fraud; They could face SEC enforcement, class action lawsuits, and personal civil liability.

Thus and therefore the 10Q for Q2 will be very interesting IF by then still no news.