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Message: BETonMACE Enrollment

"I was reading this enrollment message you sent our many months back.  Clearly the assumptions and analysis you made have turned out to be incorrect.  What exactly do you see as having gone wrong? And based on what we know now, what do you think is the total patient years now?"

The assumptions and analyses done in that message thread evolved over time and were based on the best available information at the time. Limitations and caveats were always acknowledged or implied. Hindsight is 20/20 when you look back at a nearly two year old post with limited information at the time. Many, but not all, of these assumptions were actually conveyed originally by Resverlogix and the Clinical Steering Committee. And keep in mind the number of times the bookends were extended by management for BETonMACE projected top-line. That's not on me. My assumptions and analysis evolved as new information became available. Two years ago, I doubt many, if any, thought that we'd be waiting another two years for top-line.

Many factors to consider: Limitations in enrollment-based estimates of patient years, slower than expected enrollment, unknown patient discontinuation rate, unknown placebo event rate, unknown apabetalone effect size, uncertain replication of EXAMINE trial inspired assumptions, unknown effect of additional low HDL requirement, unknown time for adjudication, cancellation of previously planned 125 event futility analysis and ~188 event sample size re-estimation analysis, change in BETonMACE protocol to allow dosing beyond 24 months, change in BETonMACE protocol to allow BETonMACE to run past 250 events.

As for patient years, I am expecting the final number to be somewhere between 3600 and 5400 but there are too many unknown variables for me to feel confident in a hard number.


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