Replies to post #16805 on NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

To keep it simple, Eloxatin was granted AA based on that trial's interim look at which only half the patients were enrolled.

And, to proclaim you are filing for AA is claiming one very obvious thing: noted stat sig efficacy. Of course that would introduce bias and nullify results going forward, results needed to satisfy the post AA confirmatory trial requirement, as per the FDA guidance that long first pointed out. It was draft at the time, but now official. Of course, based on something that had already occurred before numerous times, and reflected the direction FDA was going with AA: requiring a Ph III be already underway.

[mapman1010]

Dok as Pyrr postulates here:
http://seekingalpha.com/article/2252553-the-case-of-northwest-biotherapeutics-missing-dmc-recommendation
LP might not be aware of the AA or BLA application. the steering committee may have been given authority to do so.