NorthWest Biotherapeutics Inc (NWBO)

[WideEyed]

Beartrap12,
I agree NWBO is “waiting on the MHRA to "review and decide"....not to inspect.... not to gathering documents and information.” AND …not to ask any more questions.

WideEyed Post 755299 March 19, 2025

All,
My son spoke to Dave Innes on the phone today, so this is second hand information. Of course, Dave couldn’t say too much. He seemed to emphasize what happened recently with the MIA certificate; that they had been corresponding with the MHRA… "they (MHRA) asked questions and we would give them answers; this went on for awhile. One day after we had given them answers they gave us the MIA certificate. It was somewhat of a surprise to us. The way we’d been going back and forth with them we really didn’t know how much longer it would be. That’s what it feels like now. We’re actively engaged with the MHRA. There are no delays. They ask us questions and we give them answers. One of these days they will run out of questions and then we’ll have approval. When that is we don’t know."

When I posted the above, the next day Dave texted my son (below; I don't know how to include screenshot); he thought I could have done a better job conveying what he said. I think when Dave mentions “guide rails” he saying there is a defined process and that they know where they’re at in the process. I believe they are literally waiting on the MHRA to make their decision.

Dave Innes: Is that you out there posting?
Zach: I haven’t posted anything. I don’t have an Ihub account. My dad took it on himself
Dave Innes: Thx trying to figure out who did.
Zach: Did he say anything bad that needs to be corrected?
Dave Innes: Just sloppy. Made it sound like the process is without any guide rails which isn’t true.

10K March 31, 2025
The Company is actively engaged in the ongoing process, and the Company has decided not to attend ASCO this year in order to stay focused on interactions with the MHRA and efforts to move forward as quickly as possible.

The actively engaged is, perhaps, a reference to my post, but the MHRA is the beyond back and forth, question/answer, discussions, and information gathering. Maybe they didn't include mention of the February MIA certificate because they wanted to distance themselves from that process. They know where they are... and they are simply waiting for the MHRA decision.
NWBO’s focus right now is to launch DCVax-L and to do it right they need all hands on deck. If NWBO had gotten approval in December or January, going to ASCO at the end of May would have been a well deserved victory lap. Now with DCVax-l approval imminent, going to ASCO would be a huge distraction, even a libility. I’m not a betting man but if I were, I’d say approval is 75% for April and 25% for May.