>A pre-specified Cox multivariate regression analysis, which adjusts for prognostic factors known to influence survival, was used to test the validity of the survival benefit seen in this study.<
All that assures is that Cox methodology per se was mentioned in the statistical analysis plan. It does not imply that the way DNDN conducted the Cox analysis was pre-specified.
When in doubt, consider when. By that I mean when a company first talks about applying a particular methodology to interpret the clinical results.
In the case of Provenge, DNDN did not start talking about Cox until well into 2005, when it was already clear to management that 9902a was coming up short.
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”