A couple key observations from the poster and BIO-Europe slides.

From the Methods part of the AHA poster: "With an assumed primary event rate of 7 per 100 patient years in the placebo group, the study has 80% power to detect a 29% reduction in MACE with ABL (or 50% power to detect a 24% reduction) with 2400 patients and an average exposure of 1.5 years."

7 per 100 patient years (7% annual event rate) for average event rate. Recall back in Feb 2018, we were provided an 8 per 100 patient year figure for an average event rate. We've discussed exhaustively recently how this average event rate has likely dropped as the trial has progressed. I wonder if this 7 per 100 patient years is an updated figure. BETonMACE was originally designed to have an average exposure of 1.5 years, which would yield an event rate of ~10.5% at 1.5 years. More on this below. We've heard about some of the power calculations before.....I think it was previously stated that it had 80% power to detect a 30% RRR. This is the first that I've seen a statement about 50% power to detect a 24% RRR.

From the BETonMACE Study Design part of the AHA poster: Regarding dosing "At least 6 months, estimated mean 26 months (range 6-38 months)."

Finally, a slide/poster that accurately reflects the revised protocol in the BETonMACE trial figure! Even the BIO-Europe slide was still outdated and incorrect. A mean 26 month dosing period is significantly longer than the originally planned 18 months (due to the trial protocol amendment to allow dosing beyond 24 months). If I understand the math correctly, this would lead to ~15.2% average event rate at 26 months. Yesterday was the 3 year anniversary of start of dosing. Based on that, then dosing may continue until ~Jan 11th, 2019. But it all depends on when 250 events is hit. Slide 19 of BIO-Europe stated "last dosing still expected in late 2018." Combined, it sounds like dosing should end December 2018 or January 2019. 

BearDownAZ