"Is it possible that the powers to be that designed the BOM trial with only 2400 patients was not enough to meet the design criteria?"

Considering the current unknowns and uncertainties, then yes that it possible.

"Do you agree that the longer it takes to reach 125+ or the FA bodes well for Apabetalone as we get closer to the final analysis assuming the design criteria will get us to the 250 MACE?"

Again, too many unknowns and uncertainties. BETonMACE was modeled after the EXAMINE trial, which had a similar patient population except that BETonMACE also has a low-HDL requirement. Uncertainty #1 is whether the event rate of placebo patients in BETonMACE will be equal to or greater than (possibly even less than) the patients in EXAMINE. The drug in question in EXAMINE really had no effect, so we can compare to event rate of placebo or drug group in EXAMINE. Uncertainty #2 is to what extent will apabetalone reduce the event rate, if at all. Regardless of whether one predicts the BETonMACE placebo event rate to be the same or greater than the EXAMINE population, the obvious effect of apabetalone lowering the event rate would be to lower the number of events coming from the apabetalone arm. Since half of the patients are on apabetalone, a lower event rate in the apabetalone group would delay the 125 event trigger.

It really feels like we're running around in circles here!!!!

BearDownAZ