Replies to post #765099 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

The assessment of your response to the first RFI will be completed by Day 150 (60 calendar days after the procedure restart date) and we will notify you as follows:
If your response has addressed all our questions, we will notify you as soon as possible that your application is undergoing final compliance checks.

If we identify minor outstanding issues, we will send you a second RFI letter by Day 150 (see section 2.5).
:

The problem is this guidance doesn't apply to DCVax-L's MAA. It's probably for all intents and purposes what the MHRA tried to adhere to, but it's not "official".

Our MAA is in a bit of a Wild West, unregulated, open to interpretation category for MHRA because of when it was submitted.

I strongly think the simplest way to put it is that the DCVax-L MAA has been clocked off long enough that it is not yet in the 210+ days "clocked on" category, which means it isn't part of what is considered backlogged yet.

No math needed to break it down. That's just what it is, and we have to accept that. Easiest explanation is often correct-est.

[exwannabe]

To summarize, you are saying either MHRA is flat out lying, or NWBO has taken over 210 (or 240) days of clock off time. That is exactly what I posted 1 couple days ago.

The huge issue is, the only reason for 200+ days clock off is that they have serious questions to answer,

I remember somebody posting last year how they extra time they took to submit insured the MAA was some super well done submission that would slide through. Now you accept that it was junk (or the MHRA is lying).

OK.

[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.