NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

You all need to understand one thing.
People keep trying to convince me what NWBO plans to do, or what they mean by artisan vs. Flaskworks.
That is not my point.
My point is regulatory reality — not what NWBO may or may not be planning.
If NWBO obtains a manual-based MA and then 2, 3, or 4 months later submits Flaskworks as the intended (sole or primary) commercial manufacturing route — exactly as suggested in their last PR and in GZ’s email to me — then NWBO puts itself in a regulatory vice with the MHRA.

The MHRA has been very clear:
“The MA must reflect the intended commercial manufacturing route.”
“We generally cannot grant an MA based solely on the original process if the applicant no longer intends to use it.”

That creates an unavoidable question for the regulator:
Why was Flaskworks not the intended route at the time the MA was granted?

This has nothing to do with whether NWBO acted in good faith.
Nothing to do with whether artisan can be used commercially.
Nothing to do with what shareholders believe NWBO “really meant.”
This is about consistency of declared intent at the moment of MA.

If Flaskworks is submitted shortly after approval as the clear endpoint, then artisan looks less like an intended commercial route and more like a temporary bridge — and that is exactly where the MHRA may feel misled.

That is the risk I am pointing out. Not motives. Not optimism. Not hope.
You can disagree on how likely it is — but pretending this risk doesn’t exist is simply ignoring how regulators think.