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.