NorthWest Biotherapeutics Inc (NWBO)

[beartrap12]

I was interested in seeing the difference between where we were last quarter with Flaskworks and where we are today. Here are the two different reports from the 10Qs, both written in the Management's Discussion and Analysis section which is usually up-to-date with the current time. The difference is that we overcame the cleaning and safety issues and now have a product that is GMP-compatible.That's major! In yesterday's 10Q they mention that they "continued to work ...to reduce the footprint" so they can add more units to each cleanroom. (Note the use of past tense.) It's hard for me to tell from this comment if they were successful with reducing the footprint and if they Eden units are ready for production. Evidently, they still need to be validated as similar to the artisan method.

May Q10

Flaskworks. The Flaskworks team and Advent BioServices continued to work with the specialized contractor on the development of the GMP-grade units of the Flaskworks system. Two key areas of focus in the work have been the ability to clean the machines to GMP requirements and additional safety features for protection of the operators in the GMP setting. Enabling all parts of the machines to be cleanable to the level of sterility required for GMP operations has required changing certain materials to achieve acceptable surface properties, constructing housings around certain portions of the machines or otherwise eliminating nooks and crannies while not interfering with the movements of the machines, and other such development aspects. The Company believes the work is on track for the GMP adaptation work to be finished in the near future, and the first GMP units to be delivered to the Company soon after that.

August 10Q:

Flaskworks. The design work to make the Flaskworks system GMP-compatible was completed. This work focused on two key areas: the ability to clean the machines to the level of sterility required for GMP operations, and additional safety features for protection of the operators in the GMP setting. The Flaskworks team and Advent BioServices also continued to work with the specialized contractor on additional modifications to reduce the footprint of the GMP-compatible Flaskworks system, to enable more systems to fit into the planned Grade C labs and enable further increases in the production capacity.