Replies to post #803871 on NorthWest Biotherapeutics Inc (NWBO)

[Red_Right_Hand]

Parliament and the MHRA say otherwise

https://questions-statements.parliament.uk/written-questions/detail/2025-11-13/hl11920
Northwest Biotherapeutics has submitted a Marketing Authorization Application to the MHRA for DCVax®-L, an immunotherapy for glioblastoma. The MHRA is unable to comment on applications during the process of review, but the MHRA can confirm that this application is not affected by any historical backlogs, and the agency is assessing all applications rapidly for safety, quality, and efficacy.

https://questions-statements.parliament.uk/written-questions/detail/2025-11-11/89869
Northwest Biotherapeutics has submitted a Marketing Authorization Application (MAA) to the MHRA for DCVax®-L, an immunotherapy for glioblastoma. The MHRA are unable to comment on applications during the process of review, but the MHRA can confirm that this application is not affected by any backlogs.

https://questions-statements.parliament.uk/written-questions/detail/2025-04-17/45872
Northwest Biotherapeutics has submitted a Marketing Authorization Application to the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) for DCVax-L, an immunotherapy for glioblastoma. The MHRA is working with the applicant to reach a decision on this application, to ensure a thorough review that ensures quality, safety, and efficacy.

https://questions-statements.parliament.uk/written-questions/detail/2025-12-02/96433
Northwest Biotherapeutics has submitted a Marketing Authorisation Application to the Medicines and Healthcare products Regulatory Agency (MHRA) for DCVax-L, an immunotherapy for glioblastoma. The MHRA is unable to comment on applications during the process of review, but the MHRA can confirm that this application is not affected by any historical backlogs and is assessing all applications rapidly for safety, quality, and efficacy.

[loyallist]

Question to Grok: A message board poster claims that just after the point of Northwest Biotherapeutics MHRA application submission for DC Vax L, this filing was lifted out of the regulatory queue, and permanently set aside for forensic scrutiny by other external Agencies. Is this something that could be true, and do you know of other applications where this has occurred?

No, there is no evidence that Northwest Biotherapeutics' Marketing Authorization Application (MAA) for DCVax-L was removed from the MHRA's regulatory queue or set aside for forensic scrutiny by external agencies following its submission in December 2023.
The application remains under active review as of late 2025, with no public announcements of approval, rejection, withdrawal, or unusual investigative actions. Northwest Biotherapeutics has not issued any statements indicating such issues, and MHRA performance updates (e.g., backlog clearances reported in 2025) show ongoing processing of applications like this one without mention of extraordinary measures.
Regulatory Process Context
MHRA reviews for marketing authorizations follow standard procedures:

Validation
Assessment
Queries to the applicant
Potential clock-stops for responses

Delays can occur due to backlogs (which MHRA has been addressing), complexity of data (e.g., DCVax-L's Phase III trial used external controls, requiring thorough scrutiny), or additional information requests. However, "forensic scrutiny" implying fraud investigation or referral to external agencies (e.g., law enforcement) is not a standard part of the approval process unless serious misconduct is suspected, which would typically trigger public enforcement actions or disclosures.
Searches across news, regulatory updates, company filings, and investor discussions yield no credible reports supporting the claim. Speculative forum posts (e.g., on stock message boards) occasionally express frustration over delays, but these do not reference any official removal or investigation.
Known Examples of Similar Occurrences
I am not aware of publicly documented cases where the MHRA (or equivalently the EMA) has "lifted" a valid MAA out of the queue specifically for permanent forensic scrutiny by external agencies shortly after submission. Regulatory agencies can:

Suspend reviews if safety concerns arise
Refer matters to enforcement if fraud is alleged (e.g., data falsification)
But such actions are rare, highly publicized, and usually involve criminal proceedings or product recalls, not quiet sidelining.

Examples of high-profile regulatory investigations (e.g., past EMA cases involving data integrity issues in generic drugs) led to withdrawals or rejections, not indefinite setting aside without resolution.
In summary, the claim appears unfounded based on available information, likely stemming from misinformation or impatience with the review timeline (now over two years, longer than the requested 150-day rapid pathway but not unprecedented for complex biologics).

[CaptainObvious]

Proof?

[tucsonchas]

ballshot