"Based on BETonMACE results, the FDA encouraged the evaluation of a non-alcoholic fatty liver disease (NAFLD) subgroup as well as related exploratory endpoints....Lastly, additional data analysis from BETonMACE suggests that patients with NAFLD may experience a reduction in major adverse cardiac events and hospitalization for heart failure (MACE+HHF) when on apabetalone and top standard of care. The FDA has encouraged the Company to explore subgroups in BETonMACE2 that could differentially derive benefit from MACE+HHF reduction. "
https://www.resverlogix.com/investors/news?article=668
Today's news about the FDA rejecting Intercept Pharma's NASH drug highlights 1) the FDA's interest and scrutiny in NASH/NAFLD; and 2) underscores the excitement the FDA must have for the potential of apabetalone in NAFLD/NASH related potential. What is unclear to me is whether apabetalone has any effect on decreasing NASH/NAFLD, or alternatively that apabetalone was effective at reducing MACE in NASH/NAFLD patients.
https://www.statnews.com/2020/06/29/fda-rejects-intercept-pharmas-drug-for-nash/