Replies to post #456033 on NorthWest Biotherapeutics Inc (NWBO)

[CaptainObvious]

Its no wonder nothing ever seems to happen anywhere in this industry.

[antihama]

Thanks hyperopia for your feedback. For the most part, I believe we’re on the same page. When they apply for MAA approval, what will make Advent commercial manufacturing ready, IMO, is a specific inspection for the manufacture of DCVax-L where they will verify the robustness of the DCVax-L GMP manufacturing process along w the other GMP systems (quality, production, facilities and equipment, laboratory controls, materials, and packaging and labeling) just like a FDA PAI in the US. The biggie in a PAI type inspection is fleshed out manufacturing, packaging, and labeling details and the batch validations that go w it. So I believe they go from Specials certified to commercial drug certified simple by that detailed PAI type inspection (and the paperwork that goes w it).