NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Listening to what Dr. Ashkan said about the FDA it brings up a concern wrt getting the Journal out. Could it be possible the Journal wants the official documentation from the FDA dealing with the use of historical data vs. a control group. We know the FDA put it in Annuls of Oncology, so the support is there, but could the Journal be awaiting something official from the FDA.

As I see it, our trial is certainly groundbreaking in several ways and I could believe the Journal could want confirmation in black and white that the FDA is accepting what the company is proposing.

I'm sure that Dr. Ashkan has the picture right in terms of approval in the U.K. etc. and I suspect that if the Journal were holding for the FDA, if the company applies to the U.K. etc. prior to a Journal it wouldn't prevent them from accepting the application and approving it after their review.

Hopefully I'm wrong about this, and likewise I'm hopeful the FDA will formally establish their position shortly, but regardless, I'm sure the company is proceeding toward applying to the regulators and would only delay the FDA if told by them to wait for the formal documentation on the use of historical data for comparison. I'm of the belief that companies speak with the regulators far more often than investors realize.

Gary