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longusa

01/29/15 6:11 PM

#28798 RE: akasidney86 #28795

Yes, more of the long tail will be included with 248/348 than was the case with 110/240.

The potential downside of that is it may take longer for the 248 events to occur. We know from the enrollment interim and the BSSR using unified event rates that was done that the overall event rate was slower than expected (that is what generated the change in the enrollment, event endpoints, and PFS advantage needed).

Unless NW somehow found a placebo cohort that evented much slower than any other trial saw with SoC, then the slower event rate is attributable to better DCVax efficacy. But then it will take longer to get 248 events. NW says 248 by late 2015 / early 2016 given Sep 2015 enrollment completion. Hope so.