NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Mi D,

While I wish what you were saying was true, if it were a PDUFA date would have been established by the FDA and other regulators. I'm uncertain about all of them, but the FDA's should be 6 months later, which would be in February. If that had been the case, it should be showing up in the FDA calendar.

I'm of the belief that they're still working on the BLA. Perhaps it's nearly completed, but I would suspect that they want the FlaskWork unit qualified before they make a submission of the complete document. Of course we're uncertain if they've been doing a rolling submission all along.

As I understand the BLA, the company would have needed substantial support from contractors in developing it. Dr. Bosch should be leading the effort. Dr. Liau on the other hand should be the lead author of the Journal submission, and as necessary would be supported by other clinicians, contractors, and certainly Dr. Bosch.

If we're truly near publication of the Journal, I would have to believe that complete drafts have been submitted, peer reviewers have requested changes, or clarifications, they've been made and submitted, and perhaps 98% of it is accepted. Dr. Liau, and perhaps Dr. Bosch, could be involved in finalizing that last 2%. I don't say this as an expert, purely my opinion of how these things are done. I believe the peer reviewers must be 100% satisfied before the Journal goes to press.

Gary