NorthWest Biotherapeutics Inc (NWBO)

[The Danish Dude]

FeMike. You have signaled countless times, that you can not be bothered to read what I write.

With that in mind, thanks for providing such great due diligence - once more - not least with your endless misinterpretations and half baked assumptions, that not just signals how clueless you are, but also tells a story about your bias and possible agenda.

Don't forget folks, this AI backed research confirming that DCVax has been approved for broad cancer indications is coming from the same guy that used AI a month ago to prove that DCVax had already been approved.

No I did not confirm that. Maybe you ought to read that, which you already have a bias towards?

DanishDude, April 17:
Are we approved? Well, very probably.

Yes, as I wrote, I believed it is very PROBABLY (sorry for the spelling error), that NWBO in all but a public announcement, has received word about that. And still believe so. You are very welcome to counter that.

He knows approval is likely, it is now much more likely coming soon, and so he has to pretend like it is tumor agnostic

Don't let me in any way interrupt you in your pre-determined view of information, facts and circumstances you litteraly don't care about and even state you don't even read and then afterwards come asserting something you've obviously have read or heard from others.

Perhaps one day you'll get, that due diligence is the art of bringing forth information, to be asserted, verified or countered and refuted in order for the benefit of the collective of retailers.

That means ALSO asking what the hell the Czech Murcidencel trial is all about, and not just ridicule it, because you have a problem with AI or perhaps more the one using it.

No. They have explicitly told us that they have not. Just like they have explicitly told us that the MAA is for nGBM and rGBM alone.

I'm sorry but here is something known as due diligence, that could be too long in scope for you. If that is the case, just let it be and criticize it anyway.

Potential for Expanded Indications in NWBO's MAA Filing
Post-Validation Expansion is Possible:

Both EMA and MHRA allow post-validation expansion through Type II Variations. This can include broader indications if supported by data.

Broad Cancer Term in NHS Cancer Drug List:

Murcidencel (DCVax-L) is listed with a broad cancer term, suggesting potential application beyond just GBM.

Extended Review Timeline:

The long review time may indicate regulatory consideration for broader solid tumor indications.

MHRA and EMA Mechanisms Support It:

Both agencies have frameworks for adapting the MAA based on emerging clinical data.

Disclaimer:
Arguments and detailed reasoning are deliberately left out for clarity, brevity and to attract an audience with fear of words. This is strictly a factual summary of regulatory possibilities and NHS listing implications.

You see what I did there? I argued for something that is factually possible, backed up by several pieces of information. I did NOT however, state with certainty, tha it is going to happen. But when several pieces of information happens within a short time frame, that actually supports something, one would be a very bad "know what you are holding" person, if one didn't take that into account.

If you want me to waste my daily post on your insignificant ramblings going forward, then try at least to comprehend, what you do not read beforehand - and even state so - before letting your bias take a wild goose chase and putting words into my mouth I've never spoken.

Exwannabe's assumption:

Question: Do you think the NHS would add a drug to the list without first consulting the MHRA to confirm it’s really worth adding?

Exwannabe: Yes. It was added in 2022 before the MAA was even submitted. Why would MHRA offer an opinion on approval then?

BTW, do you think they would have a drug on the list that NICE already recommended against? Answer is yes as one can see on the entry just 3 rows above it.

I would also note that many drugs listed as requiring an IFR are not approved. Just random spot checking will confirm that.

1. MHRA's Foundational Role:
The MHRA is the UK's regulator for medicines, responsible for assessing safety, quality, and efficacy before any clinical use or market access.

Any drug listed for access, even pre-MAA, must have MHRA awareness through clinical trials or Early Access to Medicines Scheme (EAMS).

2. Pre-MAA Listing Does Not Mean No MHRA Oversight:
A drug listed on NHS pathways before MAA submission can be part of system preparedness or EAMS, both requiring MHRA input.

DCVax-L (Murcidencel) appearing on NHS lists pre-MAA does not imply MHRA was uninvolved; it may have been part of early access schemes.

3. EAMS and Clinical Trials:
EAMS, managed directly by MHRA, allows for pre-approval access to innovative treatments based on MHRA's scientific opinion.

Late-stage trials authorized by MHRA also permit NHS preparations for potential adoption upon approval.

4. NICE and IFR Considerations:
NHS may list treatments not yet recommended by NICE via Individual Funding Requests (IFR), but these still require MHRA-regulated clinical justification.

IFRs do not bypass MHRA oversight; they are case-specific exceptions under existing safety evaluations.

Conclusion:
The idea that NHS would list a novel treatment like DCVax-L/Murcidencel without any MHRA input is factually incorrect. MHRA regulatory oversight is foundational to all clinical trial activities and early access programs in the UK. Listing on NHS pathways before full MAA approval reflects strategic planning under MHRA's umbrella, not an absence of it.

Exwannabe assumption

The NHS granting IFR was done so in April of 2025, so you saying it was added in 2022 is a grotesque LIE (again) Pinokio

One can click on the "Change Log:" tab and see the old Capudencel-L entry that lists the exact same "as per IFR approval" line from 2022.

In both cases they mean that if a provider wants to use -L outside of a funded plan they must submit a request for it for the speciifc patient and say why that patient deserves what others do not get. And only a handful these are ever allowed.

But keep with the bolded LIE line when you are just wrong. It is cute.

1. Change Log Evidence Misinterpreted:
The Change Log for the NHS Cancer Drugs Fund or related listings may show a 2022 entry for Capudencel-L, but this does not equate to an IFR approval.

NHS entries often include provisional placeholders or system preparedness listings long before any formal IFR approval. These entries are sometimes tagged for future consideration or conditional use, not active patient access.

2. IFR Approval Date is Documented as April 2025:
The official IFR approval for Murcidencel (DCVax-L) was recorded in April 2025, as documented in NHS funding updates.

An entry in 2022 merely indicated potential for IFR application, not actual approval or patient access.

3. NHS Early Listings Are Not Always Reflective of Active Use:
Drugs can be listed years in advance as part of planning and readiness, especially for innovative therapies.

This listing does not imply active IFR approval—only that the drug is flagged for potential restricted access pending regulatory and clinical outcomes.

Conclusion:
The 2022 listing in the Change Log represents preparation and conditional status, not IFR approval. The actual IFR approval for patient-specific use occurred in April 2025. Asserting that the 2022 entry equals active IFR availability is misleading and not reflective of NHS access protocols.