I admit I had a narrow view of the possibilities in my message last night. I appreciate DND pointing this out. Perhaps the summary of this weekend's sleuthing is:

1) The clinical steering committee (CSC) and Resverlogix may potentially decide to forego the  sample size re-estimation analysis (SSRA). In the last 2-3 months, Resverlogix has stated that BETonMACE is fully enrolled. We've also learned that patients will remain on treatment in BETonMACE until 250 MACE events are accumulated instead of the original plan to have patients stop treatment at 104 weeks. The decision to stop recruitment and extend dosing period smells a lot like a decision to forego an SSRA.

2) If a blinded SSRA is done, this could be done by the CSC or the data safety monitoring board (DSMB). In my opinion, if an unblinded SSRA is done, this would be done by the DSMB and recommendations reported back to the CSC. Differences between a blinded and unblinded SSRA are described here. The biggest difference is that the treatment effect (apabetalone effect) would be revealed in an unblinded SSRA but not in a blinded SSRA. The blinded SSRA may focus more on the variance in the data, the control group event rate or subject discontinuation rate.

3) Resverlogix has stated in Feb and March 2018 presentation that "Projected primary MACE rate still 8.0 per 100 patient years." Resverlogix IR clarified that this figure was for all patients (placebo and apabetalone combined). If this is really based on actual obsersved BETonMACE data and all blinded parties have this figure, is there any utility for doing a blinded SSRA at this point? They already have the overall event rate, known enrollment numbers, and get updates (I think) on number of adjudicated MACE events. Add to this the recent change to extend dosing period. In my opinion, Resverlogix and the CSC have enought info to know if they'll hit 250 in 2018. Any remaining utility of an unblinded SSRA would be for treatment effect and for a blinded SSRA would be to account for variance in the data.

4) In case you need a reminder, the BETonMACE CSC is: KAUSIK K. RAY (chair), HENRY GINSBERG, KAMYAR KALANTAR-ZADEH, STEPHEN NICHOLLS, GREGORY SCHWARTZ, PETER  TOTH.