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Re: manibiotech post# 798399

Wednesday, 11/19/2025 7:54:47 AM

Wednesday, November 19, 2025 7:54:47 AM

Post# of 821343
Could be a number of issues. Could be closer to Nemesis’ version than just RFI. But at least we now know the review process is in motion of some kind and was not held up by backlog which confirms the application is going through a much lengthier ordeal than usual.

>>Answered on

19 November 2025
The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department and regulates medicine, medical devices, and blood components for transfusion in the United Kingdom, with responsibility for ensuring that medicines meet appropriate standards of safety, quality, and efficacy.

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.
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