NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I really think that it's possible that a BLA will be forthcoming even before we have UK approval, but I believe it depends on how we can accomplish commercial production. The BLA normally gets a PDUFA date that's six months after it's accepted. If the EDEN unit has not been completely accepted before the BLA submittal, NWBO needs to feel certain that it can be within say 4 months of its submission so that the FDA can inspect a production facility and fix minor problems before the PDUFA date. This would be a tight schedule, but if they know a few more month of testing will get the EDEN unit approved, they might go for it.

Of course this is based on my contention that the EDEN is needed to meet anticipated demand. Some believe Sawston with manual production could meet FDA requirements. I feel it's possible that Sawston equipped with the EDEN could do it, but I really believe that CRL will be their contract manufacturer and distributor out of the Memphis facility, and news on that will be forthcoming when the timing is right. I certainly don't know that this is possible before we have UK approval, let's hear what they have to say when they hold the Annual Meeting.

Gary