Replies to post #776719 on NorthWest Biotherapeutics Inc (NWBO)

[barnstormer]

Thanks for the response Slave. I was thinking of SEC requirements and that the addition might fall under Regulation FD guidelines, or at least was significant enough that an 8K would have been warranted.

[exwannabe]

So NWBO has added Eden to the MAA when they do not even have the actual GMP version of the device delivered and are awaiting that to start testing.

Solid theory there slave.

[GoodGuyBill]

Regarding your statement:

As for the Annual Shareholder Meetings:

• In 2022, they mentioned Flaskworks was being scaled and validated.
• In 2023, they did not say whether Flaskworks was in the MAA.
• And since then, there’s been no public confirmation of whether Flaskworks was in from the start or added later.

NWBO released this PR in Feb 2024 (Link):

Press Release 06 FEB 2024
Northwest Biotherapeutics Moves From Optimization of Flaskworks Prototype to Fabrication of GMP-Compliant Units For Installation, Validation and Final Testing Prior to Regulatory Certification

...The Company is optimistic about this approach because the Flaskworks system now closely mirrors the existing manufacturing process, and the DCVax-L products manufactured through the Flaskworks system are substantially comparable to the DCVax-L products made through the existing manual process....

...Ms. Powers continued: “We are also very pleased to have expanded the scope of our patent coverage on the Flaskworks system. We believe this is a valuable asset that will help Northwest Bio build a strong franchise.”...