NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Sentiment,
Today I had direct contact with a member of the MHRA board (not via the usual contact channels where you typically get the standard non-committal replies). Below is the full email exchange:

My email to XXXX:

Dear XXXX,

Thank you for your clarification during the Board meeting on 18 March regarding the backlog of licensing applications.
According to the minutes of that meeting, there were still three NAS (New Active Substance) applications in the backlog as of 28 February 2025, but by the end of March, the backlog was reported to be cleared.

Could you please confirm whether the Marketing Authorisation Application (MAA) for DCVax-L for the treatment of glioblastoma is among the three NAS applications that were still considered part of the backlog in February but have now been processed?
Additionally, could you kindly indicate when the decision regarding this application is expected to be published?

Thank you very much for your time and consideration.

Kind regards,

Reply from XXXX:

Dear XXXX,

Thank you for your mail.

Unfortunately, I cannot comment on the specific application. I suggest you contact the company Northwest at http://www.nwbio.com.

To confirm we now do not have any applications in backlog.

I apologise that I cannot be of more help in this matter.

With best regards,

My follow-up question:

Dear XXXX,

Thank you very much for your kind reply and for confirming that there are now no applications remaining in backlog. I appreciate your time and your efforts to provide clarity on this matter.

I fully understand that you cannot comment on the specifics of the DCVax-L application itself. However, may I kindly ask whether the Marketing Authorisation Application (MAA) for DCVax-L — which, according to the manufacturer, was submitted on 20 December 2023 and validated on 26 January 2024 — ever fell under the category of backlog at any point during your recent clearance process?

Thank you again for your consideration and for your continued transparency in these matters.

With kind regards,

Final reply from XXXX:

Dear XXXX,

To confirm this application has not been in backlog or delayed in assessment.
With best regards,
XXXX

My conclusion from this exchange:
From this conversation, I conclude that the DCVax-L application has never been classified as a backlog case, nor has it been delayed due to major objections or assessment stoppages. The MAA has remained in continuous assessment throughout, without falling into the category of stuck or problematic applications that required intervention by the Commission on Human Medicines (CHM). This supports the positive view that the application is proceeding through the normal (albeit lengthy) assessment and inspection phases, and that it was never among the applications with major issues precluding approval.