Replies to post #430892 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

The question I'd ask is, if NWBO gains approval to use the FlaskWork unit, could they use it exclusively themselves, while permitting others to make DCVax-L with clean room methodology which is already approved. If they already have the equipment, and they have facilities available, why turn them over to contractors if they aren't contractually forced to.

In the beginning I suspect that they can use all the output they can get, but as the initial demand is met and more FlaskWork units are manufactured they ought to be able to meet demands by themselves.

Gary

[antihama]

Here's my original response to MID

antihama
RE: MI Dendream post# 430663

Post#
430686
of 430904
Thursday, 12/30/2021 08:14:10 AM
Any SOPs or validation process docs that would impact NWBO's product would need to get approval or buy-in :) from NWBO and that would be spelled out in the Quality Technical Agreement that is addended to the Contract Agreement. So NWBO might not own the documents per se but then again they have control in the creation or revision to any of those documents.

I stand by what I said. You throw around IP and that I'm saying that what I'm saying is Advent will have NWBOs IP. No! Owning and maintaining these documents at Sawston will be useless to Advent if they moved to another facility. That facility, GMP suites, etc will need to be qualified from the beginning. The cell therapy manufacture will be different than DCVax manufacturing but at Sawston they own and maintain those SOPs/validations/qualifications, etc with approval/buy-in from NWBO and it's all spelled out in the Quality Technical Agreement which is addended to the Contract. Biosect, Kab, I'm not going to argue this anymore. You have your opinion/experience where you get your views and I have mine.