Biotech Values

[rkcrules2001]

DNDN -- Question for FDA mavens...

Dew's views (empahsis mine):
<<Has there ever been a trial accepted by the FDA as legitimate support for a marketing application where Cox lowered the p-value from 0.33 to 0.02? I don’t think there has been and I doubt there ever will be.>>

And:
<<If I were a reviewer at the FDA or another regulatory body, I would tell any company that comes to me with a raw p-value of 0.33 and a Cox-adjusted p-value of 0.02 to redo the trial and come back with clean data.>>

Are there examples of FDA rejecting such a trial (ie, one relying so heavily on Cox analysis) for a life-threatening disease?

And I suppose more accurately, examples of FDA rejection due to reliance on pre-specified Cox analysis? (In the last DNDN SEC filing, "Cox" analysis is discussed four times, and every time it is described as "pre-specified Cox multivariate regression analysis", presumably emphasizing that it was not post hoc.)