NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Thanks Diver,

Your thinking is very well organized, what you say makes sense if the Journal isn't waiting for something from the regulators. You previously thought Annuls of Oncology would be the Journal, what I really liked about it was that it didn't have word limitations, and also that it published the FDA's position on the sort of trial that NWBO had run. Why have you discounted Annuls at this time.

In thinking about NWBO, I suspect that they have known all along that the FlaskWorks unit would be a key to approval, and they also had a good estimate of how long that would take to happen. I believe their actions may have very well been for everything to come together at the time they believed they could get initial approval of commercial productions utilizing the FlaskWorks units.

I'm of the belief that the U.K. can still approve both the commercial production and the vaccine by the end of this year, perhaps as early as November. Of course this assumes that NWBO will be applying for approval shortly, we know they're going for the manufacturing already. I'm frankly unsure just how much credit the other regulators, especially the FDA will give for U.K. approval of the Sawston facility in judging whatever NWBO proposes for the U.S. At this point I'm uncertain if a similar facility manned by CRL will be what's proposed, or if Sawston will be proposed to meet initial demands everywhere. Clearly commercial capability is required before approval is considered, the question is just how much capacity is required to achieve approval.

Gary