I wrote the other day:

"One last side note.....slide 15 of the latest slide deck entitled "BETonMACE Current Highlights" made that statement "Projected primary MACE rate still 8.0 per 100 patient years on top of aggressive standard of care = strong unmet need." I'm not sure if that is projecting based on original trial design or making a statement from observed BETonMACE event rates. If the latter, it is not clear if this is ALL patients (placebo and apabetalone treated) or just the placebo group. I sent an inquiry to the company this morning so hopefully they will clarify this."

I heard back from Clayton about this today. He responded:

"To answer your questions, yes the actual events we are observing in the blinded analysis from BETonMACE is close to 8 per 100 patient years as we had planned. As you know this trial remains blinded and therefore, we do not have any access to who is on placebo or who is on drug, so these numbers are derived from all patients."

So if I plug in this 8 per 100 patient year event rate to the patient year estimations that I provided last week, it appears that BETonMACE should(*) be very close to hitting 188 primary MACE events, if it hasn't already, by end of Q1 2018. Using this same 8 per 100 patient year number, it appears that the original projected need of 3600 patient years to reach 250 MACE events may(*) have been overestimating the need. Since these numbers are derived from all patients, we don't know if this is due to one or a combination of: 1) the overall event rate in the low-HDL, diabetic, recent-ACS population is higher than originally projected; 2) apabetalone working better with one statin vs. the other; 3) apabetalone not reducing MACE as much as projected with either statin. My personal opinion(*) is that apabetalone is working fine, but that as described in #1 the overall event rate in this high-risk population is greater than originally projected.

* These statements are simply my opinion based upon my own interpretation of available data and my own calculations, which are subject to error. Do not hold me to any of this. Do your own due diligence.

BearDownAZ