NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

bio, I’m not presuming anything. I’ve stated that the Flaskworks culturing system could be approved for investigational use as an interim step, but it’s unclear if this is the plan, or if further validation studies are being done for the automated commercial process.

I don’t think manufacturing is standing in the way of approval either, and I agree that regulatory approval can be given based on manual production. In fact I wrote in another post that a post-approval supplement can be submitted for the change from manual processes to automated.