Led,

I'll re-post my thoughts from earlier (see below). Too many unknowns right now. 

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Great news. I have to be 100% honest.....I didn't think that there was sufficient time and/or patients left at this point in time to warrant US/FDA inclusion. But I am glad to be wrong! At last count at the 6/28/17 news release, there were over 1600 patients already enrolled in BETonMACE. We're probably closer to 1750 at this point now that we are a month later. The original goal was 2400 patients. If the 2400 patient enrollment goal still stands, then that leaves only ~650 patients to enroll until BETonMACE is fully enrolled. It's going to take some time to get US sites ready for activation/enrollment too.

How many US patients can realistically be enrolled if they stick to the original BETonMACE protocol? Will the trial investigators consider stopping enrollment in some non-US sites in order to "preserve" the space for US patients to come on board? Will the trial protocol be adapted to allow for more patients? Will they increase the total number of patients to allow for a certain number of US patients? 

Will they delay the completion of the trial to allow for US patients to have been on drug for a certain minimum period of time before the trial ends? If so, would this be done by increasing the # of MACE events to end the trial (currently set to end at 250)?

BearDownAZ