NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

I received an answer back from the MHRA and from GZ. First MHRA

Dear
Thank you for your email.
We generally require that the commercial manufacturing process intended for the MA be fully qualified, GMP- compliant, and reflected in the Manufacturers License before the MA is granted.
MHRA will typically assess the updated process as opposed to the original, especially if the applicant intends to commercialise the new route.
Timeline impacts are usually considered clock-stops, not backlog.
We generally cannot grant an MA based solely on the original process if the applicant no longer intends to use it.
The MA must reflect the commercial manufacturing route.
Kind regards,

Aleena
MHRA Customer Experience Centre
Communications and engagement team
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone [phone]

I told you all so — I was right.
I have been saying this for months, and the MHRA has now confirmed it to me in writing:
“The MA must reflect the commercial manufacturing route.”

That is not my interpretation. That is MHRA policy. What this means is very simple:
If Flaskworks is the intended commercial manufacturing route (which everyone knows it is), the MHRA cannot grant an MA based on the old manual/Cognate process, unless the intended route is fully qualified, GMP-compliant, and reflected in the Manufacturer’s Licence before MA.

The MHRA explicitly states: "They assess the updated / intended process, not the historical one."
Any delay is a clock-stop, not “backlog”. An MA cannot be granted if the applicant no longer intends to use the original process.

Now here is the contradiction: GZ has explicitly confirmed to me that manual production is (in his view) the intended commercial route.
That statement is directly at odds with what the MHRA says — and with reality. If Flaskworks were not the intended commercial route, the entire closed automated system would be economically and strategically pointless. Everyone understands this. You don’t build Flaskworks for fun.

So one of three things must be true:
A. Management knows Flaskworks is MA-critical and is not being transparent about the timing impact.
B. Management genuinely misunderstands that “the MA must reflect the intended commercial manufacturing route” — which would be astonishing at this stage.
The recent Flaskworks PR was poorly written and disclosed more than intended.

Pick whichever explanation you prefer — but the rule itself is no longer debatable.
Flaskworks is not a “nice-to-have”. It is not “later”. It is MA-critical.

That was obvious from first principles.
Now it is confirmed by the MHRA itself.


Ps from GZ

Hi XYZ
I’m terribly sorry it’s taken me a long time to respond. As you might imagine, we’ve been quite busy. Thank you for your support and query. The MAA has not been amended to account for the Flaskworks manufacturing so the MAA decision will be based on the manual method of manufacturing. The build out of manufacturing at Advent for the Flaskworks closed system has begun as you saw in our November 20 press release. If that’s completed according to the timelines suggested in the press release, we will have to file an amendment to our (hopefully) approved MAA in order to change to the faster, less time-consuming and more efficient closed system.

Let me also take this opportunity to remind you to please vote on the proxy if you haven’t already. If you have any questions about voting please let me know.


Holiday cheers,

George