Replies to post #4682 on Dendreon Corp fka DNDNQ

[walk]

>Gleason probably had little to do with it. It was more likely that the non-stat-sig finding was because of what covariates the FDA statistician left out of the model.<

That is correct. However if Dendreon had used Gleason score as one of the covariates along with the others the cox p-value would not have been as low as it was because Gleason score favored the provenge arms. If gleason had been included in the cox model I suspect that 9902a would not have been stat-sig at all. Always made me a little suspicous that Dendreon made such a big deal about how provenge works best in low Gleason scores, and even designed 9902b originaly as 7 or less gleason. Yet they fail to balance 01&02a via cox regression with gleason as one of the covariates. Which gets back to my point, that the interim analysis will have a balanced Gleason score protocol and the statistics should be somewhat worse than 01&02a where gleason score favored the provenge arms.