Replies to post #803676 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

"if the applicant no longer intends to use it."

As I said before, if NWBO intends to use manual production for one, two, or three months and then switch to Flaskworks, is manual really the intended commercial manufacturing route? GZ confirmed to me that they plan to file an amendment shortly after a manual-based MA, which puts the switch roughly two to four months after approval. Do you still maintain that manual is the commercial manufacturing route? Come on, people — let’s be realistic.

we will have to file an amendment to our (hopefully) approved MAA in order to change to the faster, less time-consuming, and more efficient closed system.”