NorthWest Biotherapeutics Inc (NWBO)

[Red_Right_Hand]

A letter from George Zavoico (received today):

We do know [[present]] that the MHRA had [[past]] a backlog when we first submitted the MAA in December 2023. We did begin [[past]] to interact with the MHRA in 2024, but the interactions were [[past]] less frequent than they were [[past]] after the MHRA announced earlier this year that they caught up with their backlog.

This year we were [[past]] much more actively engaged [[past]] with the MHRA, as we described [[past]] in our Form 10-Qs. For months we’ve been responding [[past/present]] to their queries and request for information as quickly and comprehensively as we could [[past]]. The regulators have been [[past/present]] very detail oriented, examining our processes and data very closely, so given the time, effort, and expense they’ve put [[past]] into this review, we believe [[present]] they will [[future]], ultimately, approve DCVax-L. If they had found [[past]] a fatal flaw in our application, I think they would have [[past]] let us know a long time ago.

However, we still don’t know present when they will future let us know their decision. While we believe it is 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.

[[emphasis added]]