NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Iron Mike,

You're right, just a few wealthier Americans' might go to the U.K. or perhaps Canada if they follow the British lead. Lots of Americans' will however be pressuring the FDA to act. I don't want to see shareholder as active as they were with DNDN, going to Congress, actively protesting for the approval of Provenge. I really don't believe it helped, though eventually Provenge was approved. I wish I could be certain that all the activism by shareholders didn't actually delay the FDA approval.

I actually believe the FDA is very satisfied with how NWBO has conducted themselves. I suspect the biggest issue with the FDA is the acceptance of the FlaskWorks units for commercial production, once we're over that hump I believe it will just be a matter of time until a facility is ready to be inspected for commercial production, then everything else will fall into place.

When IMGN filed their BLA and got their PDUFA date I publicly indicated that I believed the FDA could announce up to a month before the date, they did announce approval 2 weeks before the date. I believe that essentially the same thing will be true of NWBO, once a PDUFA date is established, approval is possible at any time in the last 4 or even perhaps 6 weeks before it.

Don't bet the FDA won't step up shortly after the U.K., but I'd be very surprised if they beat them to the punch.

Gary