Tada wrote "All of the phase II trials were EMA trials as the FDA never approved them on the cardio side."

According to ClinicalTrials.gov, the study locations for Phase 2 SUSTAIN were in South Africa and the study sites for Phase 2 ASSURE were in Argentina, Belgium, Brazil, Hungary, Netherlands, Poland, Russian Federation and Spain. Both SUSTAIN and ASSURE were sponsored by the Cleveland Clinic with Stephen Nicholls as the listed investigator. I did not start following Resverlogix until after ASSURE was already planned and launched, so I do not know if Resverlogix even attempted to include US study sites for SUSTAIN and ASSURE. Since SUSTAIN and ASSURE did not include US study sites, Resverlogix may not have needed to seek FDA approval. 

Their first phase 2 trial, ASSERT, did include US Study sites since Orange County Research Center (Tustin, California, United States, 92780) is listed as the only study site location in the ASSERT ClinicalTrials.gov listing. Stephen Nicholls of Cleveland Clinic is listed as the trial investigator for ASSERT as well. Since ASSERT is a Phase 2 trial and California is in the US, I am assuming that the FDA must have "approved" this Phase 2 ASSERT trial.

BDAZ