NorthWest Biotherapeutics Inc (NWBO)

[dmb2]

Lykiri and Flipper, thx for the info.

I think what the professor means is that Flaskworks is a piece of mfg equipment that will require a medical device type of compliance development documented history. When medical devices are developed there is a need for detailed design and testing protocols and specification documents to basically demonstrate they operate as intended and can be maintained as required.

Flaskworks will need such documentation since it is proprietary and it is my guess that since it was always intended to be sold to cell therapy manufacturers that all required design and development documentation was incorporated into the work done by the inventor from the beginning. Otherwise it would have been useless to a customer because it would never be approved for such use. Bottom line I am sure the required Flaskworks equipment documentation exists and will be a significant part of the certification submission.

This is an additional step of the submission requirement since typically it is a commercially available piece of equipment that is purchased and used in a new process. That being said it is a relatively simplistic and focused piece of equipment so its qualification for ultimate process certification should not be problematic and since NWBO purchased the entire package, which I am sure includes all related documentation, they should be fine. And NWBO knew how critically important this equipment would be so I am sure they possess all the needed qualification docs.