NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Hi Hoffmann6383

Project Orbis is not itself a accelerated program, but a party needs to be designated with an accelerated status to be in Project Orbis.

If they have the status in the US, they can get into Orbis, not sure that the status in the UK gives them access to Orbis. But certification of their facility for GMP would be a designation, along with a plan that was realistic for scaling manufacturing, to get them into an accelerated program with the FDA. There are other requirements but those are easily ticked off.

The focus on manufacturing, which I posted in detail on last summer, with quotes and links to the relevant documents, is for the acceleration of approval and then hopefully into Project Orbis because of that designation.