NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

You're right LongUSA…

I should have looked up the response timelines instead of going from memory. Shortest PDUFA date is 6 months (not 60 days).


Also Hodge, the FDA recently gave some new information on compassionate use. Longusa is correct, you really should see if the company could make this happen. Your Doctor will ultimately need to help you if you go through "single patient access," (or any other process).

This link should help.

www.cancer.org/treatment/treatmentsandsideeffects/clinicaltrials/compassionate-drug-use



Finally, Yes….Long is correct, they could approve this drug on phase (I/II) combined data. With this in mind, there are ways to shave some time off Long's estimate, but I think the window (after taking into account my error and Long's excellent point) is November 2015 to June 2016….best case scenario -- for commercial availability of Direct (IMHO).

I second Long's recommendation that you call NWBO and see if you can pursue compassionate use on direct.