Well, the market decided to focus on this:

"For the United States (U.S.), the Company engaged with the U.S. Food and Drug Administration (FDA or the Agency) resulting in alignment on the definition of statin intolerance, key design features of the CVOT, and the regulatory approval pathway for a CV disease risk reduction indication in statin intolerant patients for bempedoic acid. However, the FDA did not provide clarity on a regulatory pathway for an LDL-C lowering indication in the U.S. in statin intolerant patients at this time. The Agency indicated its position regarding an LDL-C lowering indication could be impacted by potential future changes in their view of LDL-C lowering as a surrogate endpoint or the possibility of a shift in the future standard-of-care for statin intolerant patients with elevated LDL-C levels. In the event LDL-C lowering is no longer a surrogate endpoint for initial approval in the future, Esperion would plan to submit a New Drug Application (NDA) to FDA for a CV disease risk reduction indication on the basis of a successful completion of the CVOT, which would include the results of the LDL-C lowering efficacy studies, by 2022."

So very positive, green light go ahead statements from the European EMA, but some waffling by the FDA. It sounds like the FDA is on board with bempedoic acid for CV risk reduction, pending trial results, but is treading with caution about whether bempedoic acid could be marketed/prescribed for LDL-C lowering. There are some other LDL-C lowering CVOT trials going on right now....so I think the FDA just wants to see these results first before providing any definitive statements.

European approval without US approval. Sounds familiar, right? Right now Resverlogix seems to be in the same boat with RVX-208. Resverlogix and RVX-208 right now don't have any US study sites or concrete path to FDA approval with BETonMACE (subject to change based upon info Don provided at the quartely update). However, Esperion's two phase 3 trials for bempedoic acid will 1) include both European and US sites; 2) is still on path for EMA/FDA approval for reducing CV risk; 3) is on path for EMA approval for LDL-C reduction; 4) possibly, but not guaranteed, path for FDA approval for LDL-C reduction.

Time-wise, BETonMACE will conclude in 2018, whereas the bempedoic acid safety/efficacy and CVOT trials won't conclude until 2019 and 2022, respectively.

I am somewhat shocked that the market responded so negatively (ESPR at 9.85, -39.12% right now) since there was still a lot of positive in the news.

BearDownAZ