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FeMike

04/09/25 9:30 AM

#759858 RE: dennisdave #759856

What are you talking about man? You're getting delusional. Nothing that I or NotSure said implies anything about rejection.

Our only point was that this NICE update does not mean that approval is imminent, which is what ATL is implying. Not that approval isn't happening.

We said nothing about rejections or the application not progressing.

Stop chasing this stuff man, read what I wrote. All we are saying as that this update cannot be used to determine a potential approval decision timeline.

So again, I ask you, please point out what I said that was negative. Show me the negative quote. Saying that a NICE update showing that NWBO is still working with the MHRA on the MAA doesn't mean approval is imminent is not negative. We're not saying approval isn't imminent (well, I do think that, but that's not what I said in this situation). Just that this update doesn't mean approval is imminent.
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NotSure2

04/10/25 4:13 AM

#760130 RE: dennisdave #759856

Dennis, nothing Femike or I have said is negative at all. Just pointing out your lies.

Also you just wrote another lie here, in bold->

If MHRA had indicated that DCVax-L was likely to be rejected or had already issued a formal or informal no NICE wouldn’t waste time updating the page just to keep it alive.



You might be right for "Formal" (after MHRA inform NWBO first) but you are totaly wrong with your "likely" or "informal".

If such (clearly illegal) backchannel existed (MHRA leaking confidential information to other agency), NICE would not write the following in their update:

See for yourself ->

Date: Update 02 April 2025: NICE is continuing to liaise with Northwest Biotherapeutics. The company (NWBO) reports that it is still fully occupied and engaged in the Marketing Authorisation Application (MAA) process with the MHRA

There is so much NO communication on the status of an MHRA application between MHRA and NICE, that NICE has to ask NWBO (or wait for NWBO) to report to them about it.

Could you imagine the legal issues if MHRA was allowed to communicate this info to NICE way before informing NWBO, lol. Might want to look into what type of confidentiality MHRA is bound towards an application from a pharma company.

Since you guys like chatgpt, see for yourself: (by the way I can easilly get an answer from chatgpt about how bad it is to feed corn to wild deer, but also how good it is, just by different way of asking.)


1. Timing of MHRA’s Notification to the Company
The MHRA will inform the applicant (i.e. the pharmaceutical company) directly and as soon as a final regulatory decision is made, including if the decision is not to approve the drug. That communication typically happens in writing within a few working days, often via a formal decision letter or scientific opinion.
• This communication is strictly confidential until the company is informed.
• The company is usually notified before any public disclosure or involvement from other agencies like NICE.
2. MHRA and NICE Do Not Share Decisions Preemptively
The MHRA would not contact NICE (or anyone else) ahead of notifying the company—even if the MHRA knows the drug won't be approved.
MHRA and NICE are separate bodies with distinct roles:
• MHRA assesses safety, efficacy, and quality for marketing authorisation.
• NICE evaluates cost-effectiveness for NHS reimbursement—but only after MHRA approval.
• No backchannel tip-offs: It would be completely inappropriate, unprofessional, and potentially unlawful for MHRA to tell NICE to cancel an appraisal before the company has been officially informed.
The company must learn the outcome first, then they may choose to withdraw their NICE submission or let it lapse, depending on the MHRA outcome.

Asking a different way, neutral again, chatgpt answer:

1. The 2 April update from NICE:
This just confirms that NICE is still in contact with NWBO, and the company is currently focused on the Marketing Authorisation Application (MAA) with the MHRA.
It doesn’t imply anything about:
• Approval being guaranteed, or
• A timeline for when MHRA will decide.
2. MHRA approval not guaranteed or necessarily soon
The MHRA could still be reviewing or even have concerns or requests for further info. Regulatory reviews are complex, and no update from NICE suggests the decision is imminent, favorable or unfavorable.

3. Confidentiality / legal constraints
If the MHRA has made a decision, either positive or negative, it’s very possible that:
• That decision is still confidential,
• The company (NWBO) and MHRA are under strict non-disclosure obligations,
• NICE wouldn’t be told until either the marketing authorisation is publicly granted or the company voluntarily discloses the outcome.


Which ChatGtp answers are more reflective of reality? DD manipulative way, or the neutral way?

*** Also, you know it is extremely easy for ChatGpt to make huge mistake right? Ask it mathematical questions follow up, youll see. % interest compound. It can do huge mistakes on super easy stuff to, or invent things out of nowhere ***