Pomp, nice summary of the placebo population comparisons. Yes, EXAMINE was the trial population that Resverlogix and the Clinical Steering Committee used to model BETonMACE. As you indicated the low-HDL and more recent ACS event requirement in BETonMACE "should" increase the risk even more. However, keep in mind that very few CVOT trials have been run on the diabetic, recent ACS populations. There's ELIXA and EXAMINE. Was EXAMINE an anomaly? Was ELIXA an anomaly? Did the modest difference in time from ACS event to randomization between EXAMINE and ELIXA really matter or was the placebo event rate difference just by chance? Would these two trials replicate the same event rates if run again today? Has standard of care improved since these trials completed to suggest that placebo event rate today would be lower? Based on the above uncertainties, it is still possible that the placebo event rate in BETonMACE may be lower than that observed in EXAMINE and/or ELIXA.

Narmac and Tada, my understanding is that the primary outcome is based on the combined statin groups (all ~1200 placebo patients  vs. all ~1200 apabetalone patients). The pre-specified subgroup analysis of the primary outcome will compare the placebo vs. apabetalone for each individual statin. So there will be a combined statin %RRR and a %RRR for each individual statin. However, the success or failure of the trial will depend upon the statistical result of the primary outcome on the combined statin group. If this fails to achieve statistical significance, then the pre-specified subgroup analyses of the primary outcome may be invalid.  A failure for the combined statin but success of a pre-specified subgroup comparison may necessitate a follow up clinical trial for FDA and/or EMA approval. All just my opinion. I may be wrong here.

BearDownAZ