Just some BETonMACE brainstorming here about number of patients, average dosing period, max/min length in trial, etc. in relation to USA and non-USA patients. Obviously, non-USA patients have a huge head start in the trial. Come Sept-Dec 2018, 600 to 800 will have already completed their 2 year dosing, with the minimum dosing period for these non-USA patients being 10-13 months and the average dosing period being at or beyond 1.5 years.

A recent news release anticipated finishing the ~2400 patient enrollment in H1 2018, which I am guessing will be largely comprised of USA patients.  Depending upon the pace of enrollment (6 month range over H1 2018), these USA patients may only be in the trial for anywhere from 3-9 months by Sept 2018 and 6-12 months by December 2018. 

As far as we know, this is still an event driven trial, meaning BETonMACE stops once 250 events is acheived. But what if we hit 250 events around the end of Q3 2018, for example. These USA patients will have only been in the trial for 9 months tops and 6 months average (assuming first USA patient enrolled early Q1 2018 and last USA patient enrolled end Q1 2018). Based on what we saw with ASSURE/SUSTAIN, very few 3-point MACE events would be contributed by a cohort of 400 USA pateints with an average treatment duration of 6 months.

Like I said, just brainstorming. Just wondering about those FDA adjustments to the BETonMACE protocol to accomodate USA patients. 

BearDownAZ