The significance of the sample size re-estimation analysis (SSRA) extends beyond its ability to confirm that BETonMACE is sufficiently powered and that current projections for required number of patients and target MACE events are unchanged. The SSRA also serves as an official timestamp for number of accrued MACE events. Recall that the futility analysis (FA) was supposed to have happened at 50% of events (125 events). However, this FA was cancelled/delayed/adapted (choose your term) and instead a SSRA at 75% of events (188 events) was planned. Since neither the FA or SSRA have been announced, we have zero clue as to how many MACE events have occurred at this point.

If the SSRA is still going to happen, then this means that 188 events have not happened yet. If the Clinical Steering Committee/Resverlogix have decided to not perform the SSRA, then this means that we may or may not have exceeded 188 events already. Without this timestamp, it is difficult to project when BETonMACE may hit 250. Sure, DM has stated top line are expected by end of year. That is not a guarantee.

Based on my numbers, if BETonMACE hits 188 events by end of June 2018, then I can see a 250 event target being reached by Nov/Dec 2018. However, if BETonMACE doesn't hit 188 events until after June 2018, then I see an increasing probability of an early 2019 date for reaching 250 events.

Importantly, it has been 3 months since the last company statement of planning to do a SSRA at 188 events. If since that March 19th news release the Clinical Steering Committee/Resverlogix have decided to not do the SSRA, then it is possible that 188 events have already been surpassed. If this is the case, then Q3 2018 is fair game for hitting 250 events. 

We could have less than 3 months, less than 6 months, or more than 6 months to go. That is the significance of having an SSRA time stamp.

BearDownAZ