NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Since the Nov 20 PR came out, I’ve quoted the PR in full more than once last time here:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=177004494

You’re missing the core regulatory point entirely. Yes, NWBO wrote that Flaskworks is key for Grade C and central for large-scale production. That’s exactly the issue:
• If manual Grade B were the intended commercial process, MHRA could have approved months ago.
Manual is already fully licensed, inspected, validated, and used for Specials. There is nothing left to review.
• If Flaskworks/Grade C is the intended commercial process (as NWBO explicitly stated), then MHRA must review that process before granting a marketing authorisation.
That is basic MHRA ATMP regulation, not “my opinion.” Your constant attempts to portray this as my opinion only show your lack of understanding of ATMP CMC review rules. That’s on you, not on me.
*NWBO has explicitly stated that Flaskworks is prepared for regulatory licensing, meaning they intend it to be reviewed and approved by MHRA as the commercial manufacturing method.

You and your fans are afraid that the Flaskworks manufacturing approval will take years, but that’s nonsense. The process is completed once the Grade C suite is finished and validated, which is expected by mid next year if you actually read NWBO's last PR. Not years

What annoys me even more, besides your lack of basic ATMP CMC update regulation, is your refusal to do basic research/homework/DD on ATMP CMC update regulation with any of the tools available online. You cannot tell the MHRA:Approve us based on manual… but we actually intend to commercialise with Flaskworks.” That would be acting in bad faith. MHRA does not approve an MA based on a process the sponsor does not plan to use commercially. I’m repeating myself, but what you and your fans are effectively asking for is for NWBO to mislead the MHRA. Good luck with that.

And again: if NWBO were to mislead MHRA by pretending manual is the intended commercial process, and they get the MA based on that and then submit Flaskworks a few months later, the MHRA would be irritated and would likely suspend the manual-based MA immediately while reviewing the Flaskworks update. Apparently, that scenario is fine for you. I thought you wanted NWBO to succeed. I want NWBO to succeed with an MA that has a commercial production future you and your fans don't.

So you can argue feelings, but the regulation is simple:
MHRA approves the actual commercial process, not the historical one.
If NWBO added Flaskworks mid-review, that creates a sponsor-side clock stop. That perfectly explains why MHRA says the application is “not in backlog” despite being far past the standard review window.

That’s not hypothetical. That’s directly based on MHRA’s own rules.
But hey whatever helps you sleep better.