Just remember, there are very few examples of clinical trials with diabetic, recent ACS patients. EXAMINE was one (ACS w/i 90 days; median 45 days). ELIXA was the other (ACS w/i 180 days; median 72 days). ELIXA had a much lower observed event rate than EXAMINE. BETonMACE has a median time of ACS event to randomization of 34 days and also has a low-HDL requirement. On one hand, BETonMACE patients may have even greater risk than those in EXAMINE because of the more recent ACS event and additional low-HDL requirement, suggesting that if 250 events haven't been reached yet that apabetalone must be eliciting a remarkable MACE reduction. On the other hand perhaps: 1) the high event rate in EXAMINE was an outlier and ELIXA is more representative of the recent ACS population; 2) the additional low-HDL requirement in BETonMACE doesn't further increase MACE risk in this already high-risk population (mean of ~43 mg/dl in EXAMINE/ELIXA; median of 33 mg/dL in BETonMACE); 3) standard of care/baseline medications in BETonMACE are better than in EXAMINE or ELIXA; 4) more recent ACS in BETonMACE doesn't pose any additional increased risk. Lots of unknowns. One thing for sure is we're closing in on the target 250 3-point MACE events and top-line data announcements! Tick tock.

BearDownAZ