NDA (New Drug Application) submission with FDA and MAA (Marketing Authorization Application) submission with EMA. FDA/EMA application acceptance. 60 to 74 days for FDA decision on priority 6-month vs. standard 10-month review. PDUFA (Prescription Drug User Fee Act) dates for FDA revidw. Supplmental NDA (sNDA). Potential FDA Advisory Committee (AdCom) meeting to discuss application. Committee for Medicinal Products for Human Use (CHMP) centralized procedure for CHMP opinion expected by Day 210 (plus the standard clock-stops for response to the List of Questions) for MAA, and final decision regarding the MAA is carried out by the European Commission. Evolution from clinical development to commercialization and promotion.

These are all things I have been watching with contemporaries in the field like Esperion with bempedoic acid and Amarin with Vascepa. If BETonMACE succeeds, Resverlogix will be facing these same next steps in the life of apabetalone. Of course, this depends on top-line and full data, but some will also depend upon whether Resverlogix decides to go it alone, Resverlogix is bought out, or if there is some kind of apabetalone partnership with big pharma. Licensing deals, like the one in Israel with Medison Pharma, will also play a role and will help with commercialization and promotion.

Esperion and Amarin aren't perfect comparisons. Esperion's bempedoic acid is going for LDL-C lowering indication, is not currently approved for any indication, and has a cardiovascular outcomes trial ongoing through 2022. Amarin's Vascepa was already FDA approved for lowering triglycerides in those with TG above 500 mg/dL and is filing a supplemental NDA for expanded cardiovascular indication based upon the REDUCE-IT trial that reported top-line data end of September 2018 and full data at American Heart Association in November 2018. Resverlogix's apabetalone isn't approved for anything yet and is taking the unconventional approach of going for cardiovascular outcomes indication without being first approved for another cardio risk factor like glucose control, LDL-C lowering or triglyceride lowering. Anyways, just putting out some resources here for folks to put Resverlogix/apabetalone timelines in perspective of these contemporaries.

Feb 28, 2019: Esperion Announces Submissions of Two NDAs and Official Completion of Two MAA Validations for Both Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet

May 5, 2019: Esperion Announces U.S. FDA Acceptance of New Drug Applications (NDAs) for Both Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet for Filing and Regulatory Review

March 28, 2019: Amarin Submits Supplemental New Drug Application (sNDA) to U.S. FDA Seeking New Indication for Vascepa® (icosapent ethyl) to Reduce the Risk of Major Adverse Cardiovascular Events Based on Landmark REDUCE-IT™ Cardiovascular Outcomes Study

May 29, 2019: U.S. FDA Grants Priority Review for Vascepa® (Icosapent Ethyl) Supplemental New Drug Application Seeking Cardiovascular Risk Reduction Indication