Although an early halt recommendation is a possibility, I recall Resverlogix stating on several occasions that they would not halt BETonMACE early primarily because they need the long-term safety data afforded by going to completion. Right now there are only ~2400 patients enrolled (half on apabetalone), theĀ longest patient on drug is ~32 months, the projected average dosing period at end of trial is ~18 months, there will be ~3600 patient years at year end, and they are only targeting 250 MACE events. Compared to most cardiovascular outcomes clinical trials (CVOTs), those are small numbers. Yes, with the high-risk patient population, they don't need as many patients or as long of trial duration to accumulate the required MACE events. 250 target MACE events is small relative to other CVOTs. Also keep in mind this is a first in class molecule and the trial needs to go to completion for that much needed safety data, in my opinion.
BearDownAZ