NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

In reality, the different regulators are doing much the same thing in different ways. The FDA provides a PDUFA date on accepting an NDA or BLA, it's normally 6 months after they accept it if priority review is granted. In the UK it's 150 days after the document is filed, plus the time it takes if they request additional information from the company. If no information is requested the UK process is faster than the FDA, and I believe they're shooting to do it in 120 days. I'm uncertain of the other regulators, but I believe they have similar guidelines.

Frankly it's to bad they can't agree on a common submission that all could agree with, but that's not the case. I've got to believe an FDA submission will have nearly every page in the UK submission, plus more on the commercial production facility, as that was resolved in an earlier submission in the UK.

I would hope that before the end of this year NWBO has filed with the three other regulators. That may be dependent on acceptance of the EDEN unit for production which is another major step. I would hope that when they have an Annual Meeting they'll provide guidance on this, and more.

Gary