Led,

I posted my thoughts on this before.

Increase # of patients: It's likely that ~1750 patients out of the original 2400 patient goal have been enrolled by now and prior to this US/FDA announcement they were already anticipating completing enrollment by this Fall. It will take some time to get these US study sites actively recruiting. It's very doubtful that they will stop recruiting at the non-US study sites. Therefore, I am guessing that they will increase the total # of patients in BETonMACE to accomodate a yet to be announced number of US patients in the trial. Not a big deal unless US/FDA wants these US patients on drug for a minimum length of time, which may or may not delay end of trial depending upon the other two points below.

Increase # of MACE events: IMO, the 125 event futility analysis won't be affected. However, it is possible that with an increased number of patients that they will increase the target # of MACE events to end the trial. This is an event driven trial, so instead of 250 events to end the trial, this may be increased to a new overall number or demanding a minimum number of US-based MACE events. It's also possible that the 250 event goal will remain unchanged, in which case we may arrive at 250 events faster now with US study site enrollment accelerating the overall patient enrollment process. 

Increase duration of trial: More patients or more required MACE events as described above aren't too big of a deal on their own. However, if the completion of the trial is delayed to allow for US patients to have been on drug for a certain minimum period of time before the trial ends, or to demand a minimum number of US-based MACE events, then this delay in BETonMACE completion may not sit well with some. It's really impossible to know what the FDA wants until Resverlogix reveals the changes. It might also be possible that some adaptation of the study allows the non-US portion to read out prior to the US portion, the latter of which may lag behind and read out later. In this way, even a larger or longer overall trial could still read out the original portion on time.

Lots of possibilities. We'll just have to wait and see how things unfold. 

BearDownAZ