NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

If true, a tail with 33% of trial patients still alive right now would be great and would justify the long trial that LP and MB have been insisting on. If these results are the reality unblinding should not be delayed.

On the other hand there has been an awful lot of talk on this MB about the absolute necessity of having a P of no more than 0.02 or 0.03 separating the mPFS and mOS of both arms with a required reduction of either P if either SS separating the mPFS or mOS of the arms fails to materialize (the juggling of the allotted alpha).

I see no guarantee that the primary and secondary endpoint will both be successful. There is also no guarantee that even if the difference between the two arms is SS with respect to one endpoint ( PFS or OS), the allotted alpha value will not be exceeded. Some on this MB believe that this would doom the trial. Having continuously emphasized the importance of the long, thick tail I have to believe that LP, MB and LL must have had enough discussions with the FDA and believe that the tail is the most important story here and will carry the trial to a successful conclusion even if either PFS, OS or even both fail. Otherwise I see no reason why this trial was extended to 36 months past the last surgery or randomization.

I welcome all reasonable alternative explanations and clarifications.