chicagoest - Top line data readout in this BOM trial is time to the 1st 3 point MACE event. It is my understanding that for the way this BOM trial is designed it is powered to show a 30% RRR with 2400 patients to produce 250 3 point MACE events over 3600 man years of dosing with all patients stabilized on either Crestor or Lipitor (50%/50%) on each and 50% of total recruits being dosed with apabetalone and the other 50% being placebo. The time to first event is measured between the dosed and placebo patient groups. Trial modification would happen at the SSA of 188 events if it didn't look like they were achieving at least a 30% RRR but not less than 25% RRR. Again through my understanding if the results to that point were at least 25% RRR but less than 30% RRR the total recruits for the trial would increase to 3600 patients to get the proper power for the trial to have statistical significance with a 25% RRR.

My understanding is that Top Line Data for this trial is time to first event after dosing had started for these 250 3 point MACE events. Alternatively it could be time to first event after dosing began for 375 3 point MACE events if the SSA suggests they are achieving at least a 25% RRR but less than 30% RRR.

This is going to be an interesting year for us.

All IMO, dyodd

tada