Many are expecting a sample size re-estimation analysis (SSRA) to occur at 188 events (75% of planned events) based upon recent company guidance and communications. To be fair, we don't know for sure if this SSRA will actually be performed. There is precedence for other "planned" interim analyses being modified or skipped. For example, there was to be a futility analysis performed at 125 events (50% of planned events) but this was not done and instead the plan was modified to perform a futility analysis at some point between 50% and 75% of planned events. Presumbably, this revised plan was also changed since the more recent company guidance and communications suggest that the SSRA will be done at 75% of planned events with no more mention of the futility analysis. 

Resverlogix has not communicated how many adjudicated 3-point MACE events have occurred to far in Phase 3 BETonMACE, which is currently targeting a total of 250 MACE events. I am assuming that 188 adjudicated events have not yet occurred; however, this may be a false assumption. Hopefully between now and the AGM on September 12th, we get clarity on this.

For the sake of the paragraph below, let's assume that 188 adjudicated events have not yet occured. The ERA-EDTA, AAIC, and CTAD posters all suggest that there are 2416-2418 patients enrolled in BETonMACE. Just to give some additional wiggle room, let's call it 2500 patients. Previous company statements from earlier this year suggested that the average observed event rate (average of both placebo and apabetalone patients together) in BETonMACE is approximately 8 events per 100 patient years. Today is September 1. There are four months, or 1/3 of a year, until the end of 2018. 2500 patients multiplied by 1/3 of a year is ~833 patient years. 833 patient years multipied by 0.08 (8 events per 100 patient years) is ~67 events. In order to reach the 250 event target by the end of 2018, there would need to be approximately 183 events right now, such that 67 more events between now and end of year could occur. This projection is highly dependent on the accuracy of that event rate number and also may not account for additional time required for the adjudication process. If it is less than 8 per 100 patient years, then we would anticipate less than 67 events to occur; if greater than 8 per 100 patient years, then we would expect more than 67 events to occur. My main point here is that the bubble is likely going to burst for those holding out for top-line data release in 2018, in my opinion. I 100% expect management to start using early 2019 or Q1 2019 or H1 2019, instead of end of 2018, as their projected timeline for BETonMACE top-line results from here on out.  

BearDownAZ