The Data Safety Monitoring Board (DSMB) does the futility analysis at 125 MACE events as well as conducts periodic reviews at certain timepoints (like the 9-month review in August). It is my understanding (and I may be wrong in this) that the DSMB does not look at the events "as they happen" but instead reviews the data at certain milestones (i.e. 125 event futility analysis, 175 event sample size analysis, periodic reviews at certain time points). We're coming up on 12 months of dosing on Friday November 11th, so it is possible (no guarantee) that the DSMB may do a 12-month review this month.

Even if the DSMB sees a trend in the data prior to the futility analysis, such as at a periodic review, they may not be able to comment on this unless there is a serious safety or lack of efficacy concern. In this manner, no news is good news.

From the August 11th news release "The DSMB reviewed available study data and noted that no safety or efficacy concerns were identified. The DSMB will conduct additional periodic reviews and will also perform a futility assessment once 125 adjudicated major adverse cardiac events (MACE) have been observed."

BearDownAZ