"What makes anyone think that we are well past 125 MACE?"
When I asked Clayton about the statement in the MD&A that read:
"The DSMB will conduct additional periodic reviews and a futility analysis is planned after 50-75% of the primary MACE events have been adjudicated. We, the clinical steering committee, and all investigators remain blinded to the actual safety and efficacy results."
Clayton responded:
"The DSMB and the clinical steering committee are in discussions as to the most appropriate timing for the futility analysis, ranging anywhere from 50% to 75% of the events. When a final decision is made it will be announced. The discussions are based solely on statistical analysis factors and not on clinical results."
Therefore, this creates ambiguity as to whether they have already hit 125 events (50% of original 250 target).
BDAZ