Amarin Corp Plc (AMRN)

[MedResCollab]

dukesking,

These are exaggerations, especially on purity. In fact we found some interesting ties behind the studies testing off the shelf omega-3 supplements, and much evidence their methods were poor, which we elaborate on in our 226-page report. In actuality, certain concentrated omega-3, including EPA-only supplements, pass more stringent standards (GOED) than the USP-NF.

But to help you a little, here you can see just how pure many of todays EPA/DHA supplements are:

https://www.nordicnaturals.com/en/Retailers/Third-Party_Test_Results/860

You may also look up these COAs here:

https://www.nordicnaturals.com/cofa/

Whether or not DHA is good or bad is something you do not know. There are obvious and well-documented benefits to DHA consumption (decrease heart rate and blood pressure, as well as anti-oxidant properties), and there is one potential detraction in increased LDL-C, but this is limited to those with very high triglycerides at baseline (> 500 mg/dL), which is a vast minority. And there is much evidence eating more fish = less risk of ASCVD, and all fish have DHA, with many genus having more DHA than EPA. So, I wouldn't be too rash in dismissing DHA, or worse, labeling it "bad".

Also, you may not be aware, but it all comes to API regarding bioequivalence and what FDA considers effective. 505(b)(2) approvals do not require outcomes studies of their own, they simply must prove an equivalent API and potency as their reference listed drug counterparts. Although these off the shelf supplements are not considered generics (and will not be considered them, unless EPA-E becomes switch-OTC someday, and it might), they in essence are. Thus, they need no outcomes studies to be used. And with so much third party testing data out there, docs can rely on that to advise their patients to use them in place of Vascepa. We even found a medical institution that carries and recommends them (they actually say "prescribe") in its in-house pharmacy.