Resverlogix stated in their latest slide deck that “Projected primary MACE rate still 8.0 per 100 patient years on top of aggressive standard of care = strong unmet need." Clayton clarified for me that this meant “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.”

Trial was originally designed planning for 3600 patient years. So if the overall event rate currently sits at around 8%, then 3600 patient years would yield 288 events. My interpretation is that less than 3600 patient years will be required for BETonMACE to hit 250 events. Koo, I have no idea what you were doing with dividing by 1.5 to get from 288 to 192.

Tada wrote “We have now had patients on the drug for 120 weeks. If I recall correctly that is a little longer than was anticipated.”

Incorrect. The original plan was for patients to be dosed for up to 2 years and for the last patients enrolled to be dosed for 1 year, giving an average dose duration of 1.5 years. This original plan is likely not the plan anymore, since Resverlogix management is currently projecting completing enrollment by H1 2018 and hitting 250 events by Q4 2018. Last patients in wouldn’t have time to be dosed for 1 year.

Extending time and extending patient count are two different things. You can increase patient enrollment without necessarily increasing trial duration. Based on EXAMINE trial data with diabetic, high-risk patients, the highest risk of experience a MACE event occurs during the first several months. So theoretically if more patients are added soon, then the number of MACE events experienced by this last wave of patients will relatively large in the next several months (e.g. first 9 months) compared to the second 9 months (months 10-18). Adding more patients now would acutally accelerate getting to the 250 goal, assuming that there is not any minimum length dosing requirement.

 Noretreat wrote “My point being that a longer trial most likely means a excellent result in terms of Relative Risk Reduction (RRR).  For example, if the RRR among test patients is half that of the control (placebo) group, then the 8% MACE rate overall would be reduced to 6% (8% in control and 4% in test equals 6% overall) and would extend the time needed to reach 250 MACE by 33% (note that the result is not 25% increase).”

 BETonMACE was modeled to expect a 30% RRR. The 8% event rate stated by Resverlogix in their latest slide deck and clarified for me by Clayton is for actual BETonMACE data for all patients (placebo and apabetalone included). If true, then the current 8% event rate is real, not projected, for all patients. So your projection of 8% control, 4% test to get 6% overall in an inaccurate interpretation of this 8% overall event rate.

 BDAZ