Another time issue to keep in mind is accumulated patient years. The status of patient years is important in order to put the overall trial duration, progress, event accumulation and event rates in the proper context.

BETonMACE was originally designed to yield 250 events after 3600 patient years. Enrollment was planned to be 2400 patients with first patient in dosed for 2 years, last patient in dosed for one year, with the median dosing period being 1.5 years. 2400 patients multiplied by median dosing of 18 months gives 3600 patient years. This works out to 6.94 events per 100 patient years. 

It has been a long time since we've heard any official update from the company on the number of accumulated patient years in BETonMACE and/or an updated value for the events per 100 patient years. For all we know, BETonMACE might not yet have accumulated 3600 patient years and BETonMACE may still be on track with the original projected event rate of 6.94 events per 100 patient years. 

In my opinion, only if we know for sure that 3600 patient years has been surpassed without reaching 250 3-point MACE events can we say that the trial is taking longer than expected. Kind of like two different clocks. A patient year clock and a chronological clock.

BearDownAZ