Dendreon Corp fka DNDNQ

[rancherho]

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. 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. See:
http://investorshub.advfn.com/boards/read_msg.asp?message_id=24563706

It would also seem that the odds for success of Vital-1 would have increased over the three year period preceding the publication of the analysis of Taxotere TAX327 asymptomatic subgroup data since the median survival of 35 months for the high dose subgroups in the 2 Ph 2 trials (n=32) were not known until the last 8 months and the GVAX high dose smaller subgroup (n=9) that subsequently took Taxotere had still not reached median survival in September when it was already >40 months. This suggests that if crossover rates to subsequent Taxotere of the PH3 high dose patients in Vital 1 is even higher, the GVAX median survival results may be even better than Ph2. In any event, the possible treatment effect based on Ph2 GVAX high dose data has increased even more than the median survival calculated by the retrospective analysis of the TAX group asymptomatic patients over the median survival of 18.9 months previously reported for all Tax 327 patients treated with Taxotere every three weeks. The caveat, of course, is that the Provenge Ph3 increase in median survival of the integrated 9901 and 9902a patient experimental arm over their mixed control group involving crossover patients treated with the lower dose of frozen then thawed Provenge, some treated subsequently with Taxotere and some not, and some non crossover patients receiving Taxotere and some not is a far more reliable indication of 9902b results than a projection of the median survival of 32 high dose patients in Ph2 GVAX in asymptomatic AIPC to Phase 3 and a comparison to a reference Taxotere control group. If 9902b's experimental arm has the same 25.9 month median survival as that of the 9901 experimental arm and it were to be compared to a 23 month Taxotere control arm, would it be sufficiently powered to be statistically significant? Who knows? In biotech, it seems that everyone should be prepared for the unexpected. All JMHO.