"Gotta think though, that if we at LEAST hit the 30% RRR (or primary end point) with statisitcal significance, we are well on our way to $20-25 U.S. minimum on some type of upward slope, just not sure if it would be an overnight jump like Amerin or not?!"

I like the Amarin comparison, but it does have some limitations. Prior to REDUCE-IT top-line, Amarin/Vascepa had already passed Phase 3 trials for triglyceride lowering and a NDA for Vascepa was approved by the FDA and Vascepa commercialized by Amarin for triglyceride lowering. The success of REDUCE-IT allowed Amarin to file a supplemental NDA (sNDA) for Vascepa to expand to the cardio indication. Amarin is scheduled to hear back on this sNDA by end of September 2019.  

Resverlogix, on the other hand, has not passed any Phase 3 trial, has not filed any NDA/MMA and has not ventured into the commercialization stage yet. Unlike Vascepa, which has been vetted by the FDA for safety during previous triglyceride lowering NDA approval (based on Phase 3 MARINE and ANCHOR trials), apabetalone has not gone through this NDA approval process before. Fish oils and other concentrated/purified omega-3 products like Vascepa have been used for years, and physicians and patients are very familiar with these.There are a lot of unknowns/risks surrounding apabetalone and BET inhibitors relative to the more familiar Vascepa. More generally, BET inhibitors and epigenetic drugs are poorly understood by physicians and patients, which likely creates a sort of "proceed with caution" skepticism about this drug class until they more definitively prove safety.

BETonMACE is unique in that it has the cognition and CKD sub-studies, components that REDUCE-IT did not have. BETonMACE has a much more narrow patient population (diabetic, low-HDL, recent ACS), whereas REDUCE-IT was not restricted to diabetics, did not have a low-HDL requirement, and did not require a recent ACS. There was a mix of primary and secondary prevention in REDUCE-IT. The only major requirement for REDUCE-IT was elevated plasma triglyerides in the ~150 to 500 mg/dL range. Therefore, the patient population in REDUCE-IT, and thus the Vascepa label expansion, will cover a lot more patients out of the gate for "on label" use. Of course, off-label is a different story.

Although the timeline for BETonMACE trial wrap up seems very similar to that of REDUCE-IT (see here), we don't know for sure what will be disclosed in the top-line data for BETonMACE. Amarin really bucked the trend by including the % relative risk reduction for their primary endpoint in the top-line data announcement. This is unusual. The market reaction to REDUCE-IT top-line may have been much different if they stuck to the norm of just stating that they met the primary endpoint and then waited until AHA in November to release full data details. Will BETonMACE top-line include a %RRR? Will BETonMACE topline include any statements or detailed data on the CKD and cognition sub-studies? Assuming that the data is positive, the components of the top-line data release could greatly influence how quickly Resverlogix moves to its new price target valuation. Top-line data, Full Data, NDA/MMA submissions, NDA/MMA approvals, etc. These are all inflection points that may influence the valuation and how quickly it gets there.

BearDownAZ