Probably going to be slow on the RVX board here today with the Thanksgiving holiday. So I thought I'd just remind everyone that tomorrow marks the 11-month mark of BETonMACE, which began dosing on November 11, 2015. Furthermore, an additional two months have elapsed since the data safety monitoring board gave its positive recommendation at the 9-month mark to approve the continuation of BETonMACE with no changes.

As stated in the DSMB news release, "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. Resverlogix, the clinical steering committee, and all investigators remain blinded to the actual safety and efficacy results." We've heard before that the futility assessment is projected to occur likely in mid 2017. But how often are the additional DSMB safety checks going to be? Every 3 months beyond the previously established 6-month safety zone of SUSTAIN/ASSURE seems reasonable. My logic here is that patients are to be dosed for up to 24 months in BETonMACE, 6-month safety had already been established, and safety checks are more informative with the patients that have been on drug the longest (first waves of enrollment). So I am just guessing here, but I wouldn't be surprised to see additional DSMB safety checks reported out at 3-month intervals (beyond the initial 6-month dosing period) after the start of dosing on November 11, 2015. Since the 9-month check was August 11, 2016, we may see additional DSMB checks reported out on November 11 (2016), February 11 (2017), May 11 (2017), August 11 (2017) and November 11 (2017). At that point on November 11, 2017, the first patients will have been dosed for 24 months and the projected 125-event futility analysis should have occured (based on original company projections it should occur in mid 2017). Additional DMSB checks beyond November 11, 2017 will not be quite at informative from a safety standpoint and would just be routine at that point since the DSMB would already have data on some patients out to 2 years. If no red flags at that point, the chances of a surprise saftety issue are highly unlikley, though not impossible.

So, the first window of 24-month dosing and most informative DSMB readouts will occur by November 11, 2017, placing this bookend 13-months from now.

Happy Thanksgiving!

BearDownAZ