Cabel

Agree with everything Bear said.  In addition, you appear to have used the 2400 patient number in your calculation even though you indicated that 200 patients were dropouts.  Using 2200, the current 5-month event rate would be about 3.8%.  If, in fact, the true dropout number is 400 at this point, then the event rate would be 4.2%.  Given the apparent problem with noncompliance in  prior trials, I am hoping that the trial management team here is being extremely diligent in monitoring for noncompliant patients (i.e. not simply relying on self-reporting or failure to show up at appointments). Remember that the patient population is quite sick and old, likely many of them have cognitive issues and may have not recognize any noncompliance (forgetting doses of drugs, taking the wrong drugs, etc.) on their own part. Under such circumstances, a true dropout figure of 17% does not seem too high. Given that many BoM patients have been now apparently been in the trial for two years, around 4% may well be a reasonable MACE rate (possibly for both control and treatment patients at this point).  Also, as Bear pointed out, BoM is a three-point MACE, only the first occurrence of CV death, MI or stroke count.

As Bear and other have pointed out, the extension of the trial is providing additional data for safety evaluation as well.  While the wait is agonizing here, the apparent low event rate is good news for patients and does not decrease the possibility of a good result for apabetalone.  Unfortunate that the company has not done a good job in the reporting of events, allowing for ongoing confusion about whether reported events are adjudicated or not, but we are getting close here. 

Jupe