Replies to post #5537 on Dendreon Corp fka DNDNQ

[walldiver]

<<Also note the bogus comparison of the benefit of GVAX shown in the phase-2 data vs. that of Taxotere shown in a much sicker population. The predicted survival time of patients before GVAX treatment was already better than the actual survival time of patients treated with Taxotere. Should that not tell them that the comparison was invalid due to wildly different patient populations? If this sort of sloppy thinking was a part of the trial design process...>>

It was a part of the trial design process. In the buildup to the trial initiation, and for awhile after that, CEGE trumpeted VITAL-1's 80% power to be stat sig if the median survival beat Taxotere's by 33%, and referred to the initial 18.9-month median survival figure for the ITT population of TAX327. This is the main reason that I'm skeptical of VITAL-1's chances for success.

[rancherho]

ocyanblue and iwfal:

Sherwin, the CEGE CEO, has discussed the fact that the subgroup of TAX 327 experimental patients who received the FDA approved dosing and were symptomatic (around 45%) had median survival of 16 months, which data was plugged into the Vital 2 model. The median survival for the same Tax327 subgroup who were asymptomatic was some 22 months. As iwfal just pointed out there were some 367 events in the comparison of the FDA approved Taxotere dose group and the mitoxantrone control group, which yielded a p value of 0.009 for a treatment effect as determined by increased median survival of experimental over control patients of 2.4 months.Using the extremely optimistic numbers for comparable high dose GVAX patients cited from Ph2 would suggest an increase of over 12 months for GVAX patients over asymptomatic Taxotere patients with 400 events required for the Vital 1 final data, projected to occur in 2H09.

The above is the case for optimism and over confidence in the final Ph3 Vital 1 results. OTOH, much more modest results could still result in statistical significance for Vital 1's primary endpoint of survival. Is the likely cut-off point an increase in median survival of GVAX patients compared to Taxotere of 4 months,, 6 months? Who knows? You make your investment decision and you take your chances. JMHO.