Paladin,

We've gone over this issue ad nauseum. Drugs are almost always approved by proving statistically significant efficacy for the primary endpoint of a Phase 3 clinical trial. Apabetalone has failed its past two trials (Phase 2 ASSURE, Phase 3 BETonMACE). Yes, if you replace stroke with CHF in 3-point MACE, then it's a different story; however, that version of 3-point MACE was not pre-specified. CHF on its own was pre-specified, but was at the very bottom of the hierarchical testing. Since primary endpoint failed, ALL pre-specified secondary endpoints are considered exploratory and not confirmatory. Anything not pre-specified is simply post-hoc hypothesis forming. So why do another trial? Well, if you want the drug approved then it will likely need to be confirmed in a subsequent trial and pass the primary endpoint. Not many examples of drug approval for something that has never passed a Phase 3.

BDAZ