Replies to post #776862 on NorthWest Biotherapeutics Inc (NWBO)

[fluteman]

Slave1 (doulos) you are a Godsend, this late in the game.
Thank you for your willingness to share your erudite knowledge.

[seekinganswers]

"anticipated", "preparing for" (AND this being 1 full year AFTER submitting the MAA).... same terms they have been using for years.
Flaskworks was not used in the phase 3 trial of DCVAX-L
Do think the MHRA is just going to say, "well, screw it, we take your word for it , sounds like a cool machine" ???

[dennisdave]

They are “preparing for additional regulatory filings and inspections relating to Flaskworks.”
This is critical language: Flaskworks is not yet included in existing regulatory filings. Regulatory approval processes for the system are pending, not underway or complete. Active integration work at Advent further confirms that the system is not production-ready or certified. No mention of regulatory submission or validation runs completed.

Flaskworks is in the pre-approval, data-generation phase not yet regulatory-approved nor fully integrated into NWBO’s official production strategy.

[JerryCampbell]

Slave1 - You fabricated those quotes.
Or perhaps your AI made them up for you?

The 2025 10--K does not contain the quote you cited about comparability testing.

For the most recent 10-K and 10-Q, searching the document for "Flaskworks EDEN" shows nothing found. So the second quote also looks bogus.

https://finance.yahoo.com/sec-filing/NWBO/0001410578-25-000598_1072379/
https://finance.yahoo.com/sec-filing/NWBO/0001410578-25-001333_1072379/

[barnstormer]

Slave, first thanks for your patience in putting up with the questions and opinions on the Flaskworks/Eden issue. I do believe you meant to reference the 2024 10-K rather than the 2025 one, but that aside. you're correct the 10-K puts to rest any possibility of the system being included in or filed as a supplement through the end of 2024 and into the 1st quarter of 2025. I say into the quarter because any 2025 activity included in the filing would be limited to the date the language was written.

The Q1 10-Q language leaves more room for speculation. Preparing for anadditional regulatory filing doesn't preclude the possibility that a filing had been done. So, was an initial Flaskworks/EDEN filing done during the quarter? Up to the reader to decide, at least to my simple mind.

[beartrap12]

Slave, Looking through the 10Ks, I found this great little nugget about expansion to other clinics:

From the Annual 10K released March 31:

Compassionate Use Program.
The Company receives an ongoing stream of requests from patients and physicians for compassionate use of its DCVax products for a variety of cancers and patient situations. The Company has been operating a Specials program in the UK for a number of years to try to help brain cancer patients where it can. During 2024, the Company established collaborations with several private clinics in London to enable the Specials program to be expanded and increased. The Company is in the process of making the operational arrangements to implement these clinic collaborations for an expanded program. The Company is also working on significant cost reductions. The Company believes that having these private clinic arrangements in place will also be quite helpful for initial potential commercialization.

Well, it sounds to me like we may begin commercialization in London facilities, as well as Sawston... or at least soon after commercialization.
Thanks for your posts, Slave1!
Looking very much forward to this week, particularly Wednesday, July 23rd!