Fish oil is a MIXTURE of omega-3 acids with EPA and equal amount of DHA (source: wikipedia: look up DHA)
In chemistry, a mixture is a material system made up by two or more different substances which are mixed but are not combined chemically (source: wikipedia: mixture)
AMR-101 is removing DHA from fish oil.
Conclusion: that does not make AMR-101 a new compound.
The analogy here is if I mix sugar and salt to create sugar-salt mixture. Removing salt does not make sugar a new compound!
Someone with confirmation bias seeks out those that agree with him/her and ignores the views of those that disagree.
By definition , I do not have confirmation bias because I actively seek out those with opposing views to see if they have any merit.
If you can provide me with links to other trials that demonstrate a drug at 4 g dose ,devoid of DHA that also lowers LDL when administered to patients with high TG's
....... well what can I say ..it would make your case.
Epadel as per patent 7,498,359 contains EPA and/or DHA
Lovaza has about 40% DHA
Show me the TG lowering, fish oil extract , drug that does not contain DHA -its called AMR101
Ethyl EPA can't possibly get NCE status, beacuse it is a decades old product and used in Lovaza also.
And it could not get NCE status in the EU and it can't get it in the US, it is basically a scientfic impossibility..
You guys NOW understand why big pharma have shown NO interest in this product??
Exactly, look up NCE (source: wikipedia):
The conclusion here is that since fish-oil pills have been approved already, which contain DHA and EPA. A drug with only DHA contains active moiety of fish oil pills and therefore not eligible for NCE.
new chemical entity (NCE), or new molecular entity (NME), is, according to the U.S. Food and Drug Administration, a drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act.
An active moiety is a molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance.