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ocyanblue

03/25/08 7:00 AM

#5532 RE: rancherho #5531

The CEGE CEO stated that the interim for the Vital 1 GVAX Ph 3 trial in asymptomatic AIPC interim occurred as modeled and not earlier.

This is what Dr. Sherwin said in the 07/10/2007 PR announcing the completion of Vital-1:

"With the completion of patient recruitment behind us, we can now estimate the timing of the pre-planned interim analysis for the VITAL-1 trial to be in 2008, probably during the first half of the year, and that we will have a sufficient number of events required for the final analysis to follow sometime later in 2009."

Technically, the 01/14/2008 PR was in first half of the year. But given that it usually takes a few weeks to process data, the event must have happened either near the first day of the year or at the end of 2007. The phrasing of the above implied expecting the interim much later in the year. So that was either a really poor job of a PR or a really poor job of projecting the event.


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iwfal

03/25/08 8:59 AM

#5534 RE: rancherho #5531

Actually, the fact that GVAX can hold its own during its ramp up period against a relatively fast acting cytotoxic such as Taxotere dosing in the control arm is a somewhat postive factor for the final look.

You do not know that GVAX 'held its own'. What was the futility bar? Did they even have one? If not the DSMB safety limit is not likely to be tripped with so few events even with tax vs placebo.