Replies to post #433821 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

I agree there are may be applicable rules in the international transport of these cells, though probably still addressable. But rather I think they are focused on the practicalities of Sawston first and then they will likely have a plan that they would have to work out with the FDA for expansion of production in the US, which their risk related disclosures in their financial statements touch on. They probably would propose multiple tracks they have in place, Sawston/Flaskworks; distributed production possibilities; and then automation here in the US also, perhaps via a partner.

I think if they have the proper documents, not necessarily a signed agreement for actual production with Cognate, they’d likely be in a decent position, especially if they have Flaskworks being validated and that looks good. That would be about approval though, in my opinion and I believe that what they have now should be enough to qualify them for accelerated approval status that would qualify them for Project Orbis.

So I think their focus will be on release of data and in the meantime, while they are waiting on that, getting as many ducks in the row as possible on manufacturing. And I hope or believe that bigger things are likely in motion behind the scenes. That’s my hope.

[antihama]

I'm a little incredulous regarding

As far as manufacturing in the US, I will admit I do not know if the FDA would have an issue with it being in Sawston. It will be logistically tricky, they will have to get the patients leuko from some hospital in the US to Sawston in 24 hours (IIUC). But the FDA does not regulate that.

According to somebody in the field who posts over on IV there are regulations on international transport of cells that play in, but I have no idea what he is talking about. But if true, could make the 24 hours tricky.

Why can't they cryopreserve the tumor using NWBOs patented method via Healthbank (NWBOish subsidiary), ship to Sawston, and then do leukapheresis. I would bet my socks (clean) that this
shipping validation has been done. I would also believe the international shipping of tumor is not a biggie but maybe trickie initially till Customs and their mama get the routine down.