NorthWest Biotherapeutics Inc (NWBO)

[10baggerz]

I'D LOVE MORE THAN ANYTHING FOR THE DELAY TO BE DUE TO SOME POSITIVE ADDITION TO THE MAA. 
I agree EDEN is by far the most logical POSITIVE reason for an extended MAA delay (with tumor agnostic, ORBIS, etc. being less than 1% possibilities).
That said, nothing NWBO has said or done in the past makes this seem likely. If you carefully read Lefty49's email from GZ, it's pretty clear that the MHRA didn't even start to issue RFIs to NWBO until after they announced their backlog was cleared on March 31, 2025. M
Unless NWBO somehow secretly worked with the MHRA to modify the MAA to include Eden (which I doubt based on past false secret regulatory theories and the fact that it seems silly to submit 1.7 million pages of NAA with artisanal manufacturing and then turn around and modify it for Flaskworks) the MHRA is just late. 
Not sure why the MHRA did NOT consider NWBO's MAA to be part of the regulatory backlog but it's pretty clear that they didn't start the MAA review in earnest until about 8 months ago. 
Whar I infer from GZ's email coupled with the advent acquisition is that NWBO has responded to all RFIs, is just waiting on an MAA decision, and is reasonably certain that decision will be approval.
George Zavoico 

From: 
[e-mail] 
To: 
[e-mail] 

Mon, Nov 10 at 10:50 AM 

Hi John, 



Thank you for your 10 years of support and patience. We would all like to know why the MHRA is taking so long. 



We do know that the MHRA had a backlog when we first submitted the MAA in December 2023. We did begin to interact with the MHRA in 2024, but the interactions were less frequent than they were after the MHRA announced earlier this year that they caught up with their backlog. 
This year we were much more actively engaged with the MHRA, as we described in our Form 10-Qs. For months we’ve been responding to their queries and request for information as quickly and comprehensively as we could. 
The regulators have been very detail oriented, examining our processes and data very closely, so given the time, effort, and expense they’ve put into this review, we believe they will, ultimately, approve DCVax-L. If they had found a fatal flaw in our application, I think they would have let us know a long time ago. 


However, we still don’t know when they will let us know their decision. While we believe it is much closer now than ever before, to manage expectations we can’t predict or even provide guidance as to when they will finally announce their decision. I’m sorry I can’t be more definitive. 



Cheers, 

George 



George B. Zavoico, Ph.D. 

Northwest Biotherapeutics, Inc. 

[e-mail] 

301-275-3301 Cell 

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