NorthWest Biotherapeutics Inc (NWBO)

[TheFollower]

Doc, I reread the PR from last June
https://www.prnewswire.com/news-releases/northwest-biotherapeutics-moves-from-optimization-of-flaskworks-prototype-to-fabrication-of-gmp-compliant-units-for-installation-validation-and-final-testing-prior-to-regulatory-certification-302054769.html

I believe the testing has been done and validated by the regulators prior to the new Flaskworks patent just issued.

From that June PR:
"Next Steps
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.

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.

Patent Coverage

The Company and Flaskworks have worked to develop strong patent coverage on the Flaskworks system. The foundational patent, with broad claims covering this closed manufacturing system, has issued in the US and elsewhere. In addition, a new patent application has been filed in regard to the new and optimized system and features.

Linda Powers, the CEO of Northwest Biotherapeutics, parent company of Flaskworks, commented: "We are extremely proud of the Flaskworks team's successful development efforts. They combined a lot of creativity with meticulous and rigorous measurements, analyses and testing. We are also proud of the efforts and expertise contributed by the NW Bio team and the Advent BioServices team. The many skill sets brought to bear together were key to the successful development."

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."