Led,

Here is my summary of the Q1 2016 webcast when Mike Sweeney addressed the futility and sample size analyses. From the text below, it sounds like the determination for more patients will happen at a separate 175 event samply size estimate analysis and not at the 125 event futility analysis. Therefore, it doesn't sound like a potential recommendation for more patients would come at the same time as the futility analysis.

"Mike Sweeney did a great job covering this. Even if you didn't like DM's presentation, you should listen to Sweeney's presentation. He comprehensively covered the logistics of this huge endeavor. Half of total study sites should be active by end of March 2016. Enrollment is slow now, but as most study sites become active, enrollment will increase exponentially. 125 MACE event target by mid 2017, at which time futility analysis will occur; 250 MACE event target by mid 2018. There will be a sample size estimate analysis at 175 MACE events at which time the trial could be adjusted to continue until 375 MACE events. Austrailia had been added as a study site and will be used if additional patients are necessary. Taiwan will be included and should launch soon. US still possible pending FDA required animal work."

BearDownAZ