Replies to post #798853 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

As long as MAA is not dependent on finishing the construction and validation and certification , then it is good . I don't believe MHRA will require all that to be done to make a decision . But if approval will come only after final validation etc , then we are many months to almost a year away I think . 

[dennisdave]

Well thisPR just confirmed what I have been saying all alone. Anyone now still claiming the MHRA will approve DCVax-L on manual Grade B manufacturing alone needs to read today’s PR carefully or stop posting here. NWBO just made the entire commercial pathway explicit:

My thoughts based on this PR
1. First of all. This fully explains the A/S increase announced yesterday. Today’s PR is not a coincidence. It shows exactly where that additional dilution runway is going: to fund the Grade C buildout, Flaskworks integration, and several million pounds of CMC infrastructure NWBO must complete before MHRA can finish the review. The timing makes the intent crystal clear. We told you the increase of A/S yesterday, well after disturbing phone calls/emails from shareholders this is whats for:

2. NWBO states directly that Grade C suites are “central to large scale-up.” That means manual Grade B is not the commercial solution.

3. Flaskworks/Eden is required for Grade C. They spell it out: Flaskworks is what converts the process from open (Grade B) to closed (Grade C).
No Flaskworks ? no Grade C ? no large-scale manufacturing ? no NICE economics. As I told all of you all along.

4. They are only now starting construction of the first Grade C suite. Construction ˜ 6 months.
Then installation ? IQ/OQ/PQ ? engineering ? validation ? submission.
NWBO clearly says manufacturing in that suite is expected Q2 next year.
That means validated/commercial Grade C = mid-2026. Exactly as predicted by me

5. The MHRA review isn’t “late.” It’s being driven by the CMC expansion the shift to Flaskworks and Grade C.
Every ATMP automation transition (Novartis, Kite, BMS, Orchard, Bluebird) added 6 to 12 months.

6. Manual-only approval was never realistic.
NWBO just publicly said the quiet part out loud:
Grade C + Flaskworks is the commercial pathway.
Manual was always the bridge, not the final route.

This PR finally exposes the real regulatory picture: DCVax-L approval will happen once Flaskworks + Grade C are complete and validated not before.

Real approval timing: MID 2026