"We are currently considering the extent to which we enroll beyond 2,400 patients to ensure BETonMACE yields 250 MACE events optimally and to include US patients."
Nothing in today's news release gives any indication of the trial extending. Resverlogix, the clinical steering committee, and all investigators can remain blinded but still know how close they are to 250 adjudicated events. We've known for over a couple months now that they've been close to the original enrollment goal of 2400 patients, but still intend to include US patients. How many US patients is the unknown. It might depend on the results of the sample size re-estimation analysis.
BDAZ