A couple of things to point out in this analyst report in regards to dosing period and interim analyses.

Dosing period is > 104 weeks dosing: On pg 9 (and in the figure on pg 10) of the report it states: "Patients are randomized to either apabetalone 100 mg b.i.d. (twice daily) or matching placebo with continued statin treatment. This treatment period continues for up to 104 weeks." However, in the recent ERA-EDTA and AAIC posters it was stated that patients would be dosed in BETonMACE for up to 36 months. The current ClinicalTrials.gov page for BETonMACE (last updated September 2017) indicates a study period of 120 weeks, which likely reflects the 104 week dosing and up to 16 week safety follow up. I emailed IR last week for clarification and they responded "The protocol was amended to allow >104 weeks dosing." We've recently discussed this issue on the board here, but I just wanted to point out the outdated info in this analyst report. 

Interim analyses: On pg 10 of the report it states: "The DSMB will conduct additional periodic reviews and a futility analysis is planned after 188 primary MACE events have been adjudicated. We feel however, that this might happen sooner with 125 primary MACE events. Topline data are expected towards the end of this year or early next year." That comment on the 125 MACE events is very confusing! That would be the halfway point of the 250 event target. Surely we are well past 125 events by now if we are anticipating the potential 188 event SSRA anytime now. My opinion is that this statement on the 125 primary MACE events is nothing more than a poorly worded statement that should be disregarded. I again tried to get some clarification from IR last week on the SSRA but all I got was "The most updated information can be found in what has been filed to SEDAR – we cannot provide further comment or selective information." So we wait and wonder.......

BearDownAZ