Replies to post #535784 on NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

You are right in the sense that 80% of Americans with GBM cannot of course come up with the money to pay for DCVax-L under the Specials program.

However, with that said, a high enough percentage of Americans diagnosed with will tap out every resource of friends and family to go to the UK and get treated and that will draw lots of notice and put the FDA under a lot of pressure from Americans of all ideological persuasions. Left-leaning folks will focus on the economic and ethnic inequities with respect to which Americans can and cannot muster the resources to get to the UK. Right leaning folks largely believe that folks who work and have a job with insurance should have an effective treatment under that insurance (only extremists think you have to be able to self-pay all the way to be worthy of life). In short, there will be a clamor from all quarters if an American company is saving lots of British lives but comparatively few American lives.

[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