Replies to post #741455 on NorthWest Biotherapeutics Inc (NWBO)

[froggmister]

I also do not recall that NWBO mentioned its intention to submit applications to
the EU. If that fact can be taken as evidence, we should also assume that any
potential treatments developed from the combo trials at UCLA, Roswell
Park, the DCVax-D trials and any future partnership trials, will be limited to
the UK market. What a waste that would be.

Les Goldman on Aug, 2023 Big Biz Show:

The first one will be to the MHRA in the UK which is allowing us to do this specials program even before we file, but we're we're getting much closer to being finished up with 1.7 million pages long it's got 27 modules uh it's being double checked now to make sure that it’s completely consistent. So we'll be applying there, and we'll be applying then to the other places that gave us permission to do the trial, that was four different countries including the UK, including Canada, and including Germany and we'll be filing in order in each of those places for a commercial approval and then we will go into operation on a completely commercial basis.

[skitahoe]

I know some people don't agree, but I don't believe the current manual production facility approve for use in the UK has sufficient capacity for the UK along, if that's true, until they have more capacity filing with other regulators isn't possible. The EDEN is the key unless someone's building lots of tiny cleanrooms somewhere. I don't believe that tiny cleanrooms are being built by anyone, I believe the company, and any contract manufacturers, are waiting for the EDEN.

I believe the company is working on what's needed to file with each of the regulators, but nothing can be done until a commercial production facility can be inspected as part of the process in considering approval. No approval can be granted if no production facility exists.

Gary

[FeMike]

I also do not recall that NWBO mentioned its intention to submit applications to
the EU.

EU, or UK?

They haven't really mentioned EU, either. And they haven't applied in the EU. Not sure what your point is here.

If you meant to say UK, with the implication that they never mentioned applying in the UK but have done so, you're wrong.

They discussed plans to submit an MAA extensively before doing so.