Between discussions amongst Resverlogix, the BETonMACE clinical steering committee, the FDA, and the EMA, it was decided to do 3-point MACE long ago. The regulators wanted the hard 3-point MACE as the primary endpoints, with the broad 5-point MACE as secondary. This is pretty standard in contemporary CVOTs.  Amarin is a rare exception in recent years to have been allowed to have 5-point MACE as primary endpoint. With apabetalone failing its last trial, having a novel and unproven mechanism of action, using a drug not yet approved for any indication, and not yet passed any Phase 3 trial or run any trial longer than six months, it is not surprising that regulators didn't allow a 5-point MACE BETonMACE trial in my opinion. I'm sure Resverlogix wanted the 5-point MACE but the guidance that they received likely indicated that EMA/FDA approval on BETonMACE data alone would be less likely with 5-point MACE as primary outcome. 

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