Nice opinion/insight from Aureus over on IV. Perhaps that Jan 11th news release was not just permission to include US patients, but an overall FDA acceptance of the BETonMACE trial and its results regardless of US patient inclusion.

"FDA And Protocol / Enrollment News

FDA Accepted the Protocol Jan 11. I believe this meant that the FDA agreed to accept the trial data regardless of where patients were / are enrolled. I think its easy to confuse the enrollment of patients in the US with the FDA accepting the Protocol itself and the data that will come from the trial. I believe the trial is sufficiently powered by design to show stat significance if RRR is 30 % or greater. So if SSA does not require increasing number of patients we will have achieved the 30% minimum goal at 188 events and FDA will accept the data at trial end of 250 events and monoriting. Great news, shortest path to registration at least cost. All just my opinion"