Tada wrote: "I read the publication SP436 over a couple of times and wondered whether it was just the patients in the CKD sub study with eGFR <60 that would go out to 36 months or if it would be all patients in the BETonMACE trial that would participate up to 36 months. Do you have any thoughts on this?"

Assuming that any(*) patients really are eligible to be dosed beyond 24 months, few patients in the entire ~2400 patient population will get to 36 month point if the trial ends by end of 2018. First patient was dosed November 2015; first enrollment update was September 2016 with ~600 patients, followed by an update of ~800 patients in December 2016.

My opinion is that all patients in BETonMACE trial would be eligible to participate for up to 36 months, not just the CKD sub study patients (**). Based on enrollment numbers (not accounting for deaths or discontinuations), and assuming that the trial ends by end of 2018, most patients (~1600) will be in the 6 month to 24 month range; up to ~800 will be in the 24 to 36 month range; and somewhere between 1 and 600 (likely closer to 1 than 600) will reach 36 months.  

Along those same lines, if there are about 300 patients in the BETonMACE CKD sub-study, then likely these trickled in between November 2015 and of enrollment in early 2018, as opposed to all ~300 CKD sub study patients being recruited early on. So likely very few CKD sub study patients will reach 36 months.

(*) In every Resverlogix presentation discussing BETonMACE design to date, as well as in the ClinicalTrials.gov and EU Clinical Trials register pages, dosing period has been conveyed as up to 2 years.

(**) If dosing up to 36 months is allowed for all BETonMACE patients, then the idea of trial costs decreasing as 2018 progresses is flawed.

BearDownAZ