Hartland,

According to today's NR, BETonMACE has now enrolled 1600 out of 2400 patients. The trial is two-thirds of the way enrolled with 800 patients to go. Full enrollment expected by Fall 2017. Assuming full enrollment by end of November 2017, then there are 5 months to go until full enrollment. That works out to about 150 patients enrolled per month between now and then. I don't anticipate the futility analysis until end of August at the earliest (only my opinion).

So by the time of a futility analysis near end of August 2017, there will likely be around ~1900 patients enrolled with all of the planned non-US study sites open, active and recruiting/enrolling at full swing. Even if US/FDA gives the okay to enroll in the current BETonMACE, it takes time to get these sites online. By the time the US would be recruiting in this hypothetical scenario, there would likely already be 2000 or more patients already enrolled. At that point, with only 400 or less patients to go for full enrollment, it doesn't seem that likely for US involvement.

So personally, I don't see US/FDA involvement in current BETonMACE unless the sample size estimate analysis (assumed to occur at 175 events per Mike Sweeney) recommends more patients/MACE events. And without knowing the date that we hit 125 events for the futility analysis, it is a crapshoot to try to predict when we would hit 175 event mark for the sample size estimate analysis (sorry Led). All in my opinion.

BearDownAZ