" I'm very happy to see your comments  about the % RRR. It has been my understanding from day one that for a CVOT trial with this few patients that they would need a minimum of 30% RRR in order to have the statistical significance necessary for the payors to be satisfied paying for the drug. If 30% RRR was not achieved then it would be necessary to add 1200 more patients to the trial, achieve 375 three point MACE and have a minimum of 25% RRR to meet minimum statistical requirements necessary with that now larger trial size."

You're making my head spin Tada. If they don't have the statistical significance to claim that they successfully achieved their primary outcome of BETonMACE (time to first occurence of 3-point MACE), then BETonMACE will have failed, meaning no NDA/MMA applications to the FDA/EMA, meaning this drug won't come to market based on BETonMACE data. They are skipping the SSRA, meaning they are banking on the ~2400 patient enrollment and 250-270 MACE target. The SSRA was their chance to evaluate if increasing enrollment/target MACE was warranted. Maybe we are on the same page here, but from your post I don't think so.

BearDownAZ