Replies to post #776893 on NorthWest Biotherapeutics Inc (NWBO)

[beartrap12]

Slave1, Yes. We may - or may not - have to wait for the CHM meeting July 24th and 25th. That committee actually only recommends to the MHRA board what to do with an MAA . The MHRA makes the final decision (I'm pretty sure). I'm not so sure we need another CHM meeting, but let's assume we do. Then it actually makes sense that July 23rd was chosen as the date when SI-87 came fully on board. The CHM meeting immediately follows, and we have a decision by MHRA this week or next. Of course, it could come whenever MHRA gets to it, but I personally can't see them taking any longer.

As for the London cliniics that Linda Powers was signing up for manufacturing under compassionate care and commercialization, the quote below is from the Annual report and is written in the past tense. So in my very humble opinion, it is quite possible that management already has those facilities up and running for compassionate care under artisan or EDEN manufacturing if those clinics already owned C cleanrooms that were available for them to use. I emphasize, we do not know if the clean rooms are now available and we do not know with which manufacturing process they will begin. What we do know is that this whole process has taken longer than we expected and almost certainly longer than management expected, so if we don't start immediately with EDEN, IMO it will happen soon.

I also want to address IFR. I believe Individual Funding Request (IFR) is already in use and makes for an easy roll into commercial manufacturing for whatever cancer(s) MHRA approves. After commercialzation, I believe IFR will continue to be used to make DCVax-L available to patients with whatever cancers MHRA did not initially approve. And I believe those patients will be part of whatever decisions MHRA makes for approving an expansion of NWBO's commercial license in the future.

Stated in the management discussion, pp. 23-27 of March 31 annual report:

During 2024, the Company established collaborations with several private clinics in London to enable the Specials program to be expanded and increased.

The Company believes that having these private clinic arrangements in place will also be quite helpful for initial potential commercialization. ?