NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Thanks Slave,

I wonder if the FDA could tell NWBO that they'd consider the UK filing to be a BLA under Orbis, but because of Orbis it shouldn't be revealed.

I'm not saying this has happened, but if this was done under Orbis, the trial could be taking so long as the company, or its contractors, could very well be answering the questions from all four of the regulators participating in the Phase 3 trial.

If any, or all of this were done under Orbis, but if the regulators couldn't reach a common agreement, I don't know that we'd ever be told. I suspect the UK would announce approval and over a reasonably short period of time others could concur with the UK decision and rapidly approve our vaccine.

We all need to remember how long it took during the trial halt for all the regulators to agree on a path forward. I believe an agreement of all four of them under Orbis would be much the same.

Gary