NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

DJPele,

FDA does not require the final method of manufacturing chosen to be fully approved and validated before submission but it needs to be completely in place I believe one month before an application decision if that is the process chosen for the approval. In other words, MHRA could be considering artisan primarily with Edens being looked at separately but along side while FDA could be looking at the same but with Edens part of the application if it is expected to be ready by the time of their need of it for a final decision based on it. Best wishes.