NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

If DennisDave's assumption is right, and MHRA is waiting on this new ECA guidance, then comments wrapping up today means that it will be discussed internally for a month or two before being rolled out probably another month or two after that. If that's what we're waiting on, we're looking at Sept/Oct decision. If that's not what we're waiting on, we're looking at rejection

Then it's probably not a great time to tell you that the MHRA has postponed the deadline for public comments by two weeks:
https://www.gov.uk/government/consultations/mhra-draft-guideline-on-the-use-of-external-control-arms-based-on-real-world-data-to-support-regulatory-decisions

We invite feedback on the clarity and wording of our new draft guideline on the use of external control arms based on real-world data to support regulatory decisions. This consultation closes at 11:59pm on 14 July 2025.

I regret every penny I ever invested in this POS. It's not because the stock price is tanking — it's because of the immense risk this stock carries.. But now that I'm in, I'll wait until the MHRA decides. And I don’t believe it will take months after July 14. The MHRA has already finalized the guidelines and is likely processing the relevant feedback as it comes in. That said, I really don’t like the two-week extension.

This was always a high-risk stock gamble because Powers submitted a Marketing Authorization Application based on regulatory assumptions, not on existing MHRA guidelines. What we're seeing now, including the drop in market cap, reflects that exact risk (alongside an overpaid and underperforming management team). Over the years, posters have obsessively hyped the science (with constant references to the JAMA article) — which is fine. But almost no one talked about the enormous regulatory risk of submitting an application without a clear regulatory framework in place. So what you see is what you get. Non-revenue biotech is already risky — but submitting an application without an established regulatory framework makes that risk 10x higher than with most other biotech stocks.

On a more positive note: if the MHRA really had no intention of approving DCVax-L, they would have likely issued a rejection months ago. And they certainly wouldn’t have initiated a new ECA/RWD guideline in the middle of the process. And thats why Im waiting for MHRA descion

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