NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

I do not think manufacturing is holding up anything. I do think they need a practical plan to meet demand to get invited to participate in Project Orbis, but the way the FDA is going, Orbis may not be all that important if they get approval elsewhere first. The UK has the commonwealth and Canada and Australia are part of that.

Orbis is driven by the FDA. It is basically a program that allows the traditional laggards on approvals to piggyback off the FDA resources that approve much faster.

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.