Replies to post #5246 on Dendreon Corp fka DNDNQ

[walldiver]

<<FWIW, The CEGE CEO responded to a question after a recent presentation that there is no provision for stopping Vital-1 for futility since all Vital 1 patients in the experimental arm will have been treated at the time of any interim.>>

Then he's blowing smoke up the butt of whoever asked that question. If there are more deaths in the experimental arm, the DSMB will let everyone know and then the experimental arm patients will all be urged to take Taxotere. The remainder of your post IMO still overemphasizes the importance of a very small sample of patients in a single-arm, nonrandomized trial at a top cancer center.

[iwfal]

My comment wrt the powering of Vital 1 and to its Hazard Ratio of 2 assuming a 23 month control arm median survival and a 35 month experimental arm median survival was based on a response provided by iwfal on Ihub (other than using a 22.5 median survival for the control arm) since I make no claim to being a statistician.

My point was that they tout a 80% powering. For the number of events that you quoted for the interim (200) 80% powering does NOT correspond to a 22.5 mo median survival in placebo and 36 mo median survival in treated. No way, no how.

Therefore the mgt must be assuming something more along the lines of an HR=1.3-1.6 (a WAG). Something more in line with 9901 expected HR at an interim.