Replies to post #741464 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

WHERE do we stand with EDEN ? What do you know and what NOT ?

The last status info I know of are:

Feb 2, 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 next step is to have GMP-compliant (i.e., clinical grade) versions of the prototype Flaskworks machine made with GMP grade materials. A specialized contractor has been engaged to do so. This process is expected to take several months, in part due to ongoing supply chain issues. As soon as the GMP-grade units are delivered, Advent BioServices will undertake final qualification and validation of the GMP units and use engineering runs with the system to collect data in order to submit an application to regulators to approve the use of the system for production of DCVax-L for patients.

June 2024 ASM

So now that the adaptation for clinical grade GMP, that design work has been done. The remaining steps are; complete the the streamlining, or condensing some of the portions of it, get the units ordered, have the units delivered, and then Advent will need to conduct a large amount of, what are referred to as, engineering runs. They're practice runs. You have to run, do practice runs with the Flaskworks machine in the Sawston facility, collect all the data, compare the data with the data from the DCVax products produced by the existing manual process, because they have to show, they have to demonstrate to the regulator, not only that the Flaskworks machine operates properly, doesn't shed particles into the clean room air, things like that.

So, in Feb all they had completed "optimzation" and all they had to do was production engineering for GMP and order the units to start the validation ad test process. But in June they added steps to streamline and condense the units and have yet to announce they ordered them.

IMO, ether they are spinning the status or found issues. The later is not unreasonable, creating complicated equipment often goes through various cycles. But if so,, nobody knows when (if ever) they a commercial ready version. Any rational company would order some units even if not as small as they want. Start the evaluation process as it could be a long time.

P.S.: The process once they have them is extensive. Will save that for another post.