Gold during CC: DNDN will only be told if Provenge bettered its allocated alpha at the interim look in 9902b in mid 2H08, and if not, only that the trial will continue. How does that tie into any expectation about an interim result greater than allocated alpha but less than statistical significance being "additional clinical efficacy data" reported in the CRL and allow for filing an amended BLA?
His response more or less parallels that of the CEGE CEO. Assuming, for discussion: (1)equivalent results for Provenge and GVAX, and as their CEO projects now, (2)CEGE' Vital-1 interim results in 2Q08, and (3) DNDN's lead in BLA preparation, the race to be the first immunotherapy in AIPC/HRPC will be on. CEGE's Vital-2 interim, where the ITT arm of symptomatic AIPC/HRPC patients takes GVAX and docetaxel together every three weeks, is now projected to occur around 1Q09, implying that the trial should have enrolled its 400th patient recently. My WAG remains that both Provenge and GVAX will receive FDA approval in 2009.
