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Re: asmarterwookie post# 247422

Saturday, 01/02/2016 4:24:37 PM

Saturday, January 02, 2016 4:24:37 PM

Post# of 346050
As a reminder, SUNRISE is designed as a Phase 3 registration trial and has two planned interim analyses. The first interim analysis, which will be conducted when 33% of the targeted overall survival events are reached, is for futility and the second interim analysis for futility or predictive success, will be conducted at 50% of events. To protect the integrity of this double-blind trial, an independent data monitoring committee has been established to evaluate safety data on an ongoing basis and make recommendations to Peregrine as to when the trial should be unblinded. As the interim analyses are triggered after pre-specified
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