NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I may be mistaken, but I don't believe the tiny biotech's pay nearly as much as BP's do for filing, or other fees that are part of the system. The BP's have always been thought to have substantial influence over the FDA as they pay so much of its budget.

I don't know if, or how much NWBO must pay to file, if anyone does please let all of us know.

I don't believe that the cost of filing is delaying NWBO at all, I still believe they want the EDEN qualified to meet US commercial demand prior to approval, and their filing will be at a time they are reasonably certain that will be achieved. Remember, the PDUFA date is set 6 months after the BLA acceptance. If they felt certain their production facility would pass inspection 4 or 5 months after filing, they could do so before everything was deemed accepted. I also still believe that US production will probably be done by CRL, so that relationship would be formalized prior to submission, if I'm right.

Gary