FOI release

Northwest Bio DCvax-L

This request was refused in full, so we didn't provide the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2025/00775

Received 28 July 2025

Published 9 September 2025

Request

I am writing under the Freedom of Information Act 2000 to request the following information regarding the marketing authorization application for DCVax-L, a personalized dendritic cell-based vaccine submitted by Northwest Biotherapeutics: Has the MHRA accepted and validated a Marketing Authorisation Application (MAA) for DCVax-L? If so, on what date was the application validated? Is the MAA for DCVax-L being reviewed under the 150-day accelerated assessment pathway? Has the Commission on Human Medicines (CHM) reviewed or advised on the DCVax-L application? If so, please provide the dates of any relevant CHM meetings. Has the MHRA completed its assessment of the application or issued a decision regarding approval? If a decision is still pending, please provide the current status of the review. Have there been any regulatory clock stops during the DCVax-L assessment process? If so, when and for what reason? I understand that some aspects of this request may be commercially sensitive. However, I am only requesting factual status updates (e.g., dates of submission, validation, and review phases), not detailed content of the application. Thank you in advance for your time and assistance. Please do not hesitate to contact me if further clarification is required.

Response

See attached

Documents

• FOI2025_00775 (redacted).pdf (1.1 MB)

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