Replies to post #661351 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Reg,

The EDEN unit is the unit being developed by FlaskWorks, which is wholly owned by NWBO, that's about the size of a printer and will make DCVax-L in an automated manner in a disposable cassette that will be provided by St. Gobain's Glass. In the UK they have sufficient manual manufacturing at Sawston to have that facility certified for commercial production in the UK, and perhaps elsewhere.

Ultimately once it's approved the EDEN unit should take over commercial production everywhere, but we've not had an update on the progress they're making toward that approval since the last Annual Meeting, over a year ago.

I'm still of the belief that the company wants this prior to the other regulatory submissions, or at least by the time their production facility must be inspected as part of the acceptance process. The company has not stated that, some believe Sawston is adequate with manual production for initial approval and that's certainly possible.

I do believe that nearly 99% of what was submitted to the UK will be in submissions to the other regulators, so it shouldn't be a monumental task, however the UK did approve the production facility first. The submissions to the other regulators would need to include information on the commercial production facilities, and the regulators would inspect those facilities as a part of the overall acceptance.

The UK has far more experience with DCVax-L because of its compassionate use program where patients have paid for the DCVax-L and it has been used in several other cancers besides GBM. I don't know if anyone outside the company and its contractors know if in approaching the UK they're including data from compassionate use, and other early phase trials that did use DCVax-L in other cancers in attempting to get a tumor agnostic label. Achieving such a label with a regulator would be a real game changer, but it certainly should be considered a long shot if they're trying it at all.

I really can't say when they'll hold an Annual Meeting, clearly it's late as the last one was held the end of December in 2022. That one was nearly 18 months from the prior one, but to call it a meeting for 2023 I would think they need to hold it shortly. It seems like in the OTC they're very loose with what companies are permitted to do unless shareholders take legal action to force their hand. I would rather have the company choose when to do it than force the issue, but it could be forced if shareholders take them to court as I understand it. I believe the Annual Meeting will provide guidance on when the company intends to approach the other regulators, and perhaps also when additional trials are anticipated to begin. Also it certainly should update the status of the EDEN unit.

Gary