Replies to post #798090 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

I disagree with the idea that “2024 was wasted because of MHRA backlog,” 2024 WAS active. Just not on the CMC side.

We know almost 100% that
A. June 2024 (I forgot the exact date) CHM reviewed the DCVax-L clinical data.
So the clinical module was already moving.

B Summer 2024 NWBO received the first MHRA RFI
Which means the review had already started despite the backlog.

C Sept–Dec 2024 MHRA conducted trial-site inspections
Clinical verification (sites, CRFs, PI compliance).
Inspections are NOT impacted by backlog capacity.

So 2024 handled the clinical review + inspections + initial RFI cycle. And that’s exactly why 2025 has been dominated by the real heavy work: CMC and the manufacturing pathway (manual vs. Flaskworks), comparability, QA/QC, equipment qualification, etc.

The timeline fits perfectly:
2024 clinical work + first RFIs
2025 CMC/Flaskworks deep review

There’s no time conflict. The delay sits entirely in manufacturing, not in the trial.

[2B_unknown]

10baggerz,

"Not sure why the MHRA did NOT consider NWBO's MAA to be part of the regulatory backlog but it's pretty clear that they didn't start the MAA review in earnest until about 8 months ago."

I may be mistaken, but as I remember, Moderna was ahead of DCVAX in the MHRA line-up, and they put a huge time consuming effort into trying to get it approved in the UK, at the expense of DCVAX being considered in a timely manor?

tbu