NorthWest Biotherapeutics Inc (NWBO)

[lefty49]

George Zavoico

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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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