NorthWest Biotherapeutics Inc (NWBO)

[Maverick0408]

PM,

Please don’t trust anyone that say Flaskworks is required for regulatory approval. It’s not. As I have said, me and my team have had successful 510k (FDA) and medical device CE (Europe) certifications for class II and III products. None of them required us to guarantee a certain volume. It’s always about quality and compliance of the manufacturing facility from a production point of view.

To your question about the Flaskworks, it can and will be handled separately from the MAA. Flaskworks certification will be a process similar to MIA and that can be added at a later stage.