Replies to post #5080 on Dendreon Corp fka DNDNQ

[mouton29]

Others have a firmer grasp of the deails than I -- my memory for this has faded as has my interest in the stock -- but this all started out with the original time to progression and time to pain results showing significance in gleason 7 and under but not above. And this was explained by reference to data indicating that the target antigen is not expressed so much in the higher gleason scores -- there is at least one paper supporting that conclusion (Goldstein?). So the new trial was set at gleason 7 and under.

Then in came the survival results, showing benefit across all Gleason scores. So that rationalization about expression of PAP was abandoned and eventually the SPA was amended to increase enrollment and open the ongoing trial to all Gleason scores.

Now it is true that in general the FDA does not require a demonstration or full understand of the mechanism of action, but I guess having some understanding of what it is would enable one to better design the target patient population.

[walldiver]

In 1/04, DNDN released news that interim survival data was stat sig for the Gleason 7 or less subgroup in the 9901 trial. Then in 10/04, the final survival data came in and it was stat sig for the entire intent to treat group (p=0.01). There is a lot of info in the ReadMeFirst page for DNDN.