Amarin Corp Plc (AMRN)

[Biobillionair]

The next two weeks for Amarin:

Lovaza's Label has changed, this foreshadows the FDA's thought process.

"LOVAZA is a combination of ethyl esters
of omega 3 fatty acids, principally
EPA and DHA, indicated as an adjunct to
diet to reduce triglyceride (TG) levels
in adult patients with severe (500 mg/dL) hypertriglyceridemia."

I speculate we see the EPA & DHA dropped completely from the label and the mix HIGHLIGHTED. The RLD definition includes the other five Ethyl Esters, the last thing the FDA wants is additional Omega 3's added to the label of unknown pharmaceutical activity, this was their mistake years ago. We're also likely to see a "wild (EPAee)" change as also referenced in the RLD.


From the new API Reference guidance posted in 2012 for Lovaza:

"Omega-3-Acid Ethyl Esters is a natural source drug obtained from
the body oil of several fish sources. The Omega-3-Acid Ethyl Esters USP monograph defines the active pharmaceutical
ingredient (API) as composed of seven individual omega-3-acid ethyl ester components. The Omega-3-Acid Ethyl Esters
Capsules USP monograph 3 establishes ranges for the two most
abundant components (EPAee and DHAee) of the active pharmaceutical ingredient (API) and ranges for the sum of the two components. The reference product contains lesser quantities of the other five omega-3 acid ethyl esters, although quantitative ranges are not specified in the USP monographs. The Agency has determined the quantitative ranges of the other five omega-3-acid
ethyl ester components based on assay of multiple batches of the RLD using the USP monograph analytical method."

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Why you should care? Routine maintenance before the FDA !!!FINALLY!!! clears the air around Vascepa's exclusivity. This label has to be posted by July 10th...next OB...12th. Waiting, impatiently...
I'm seeing many GSK connections behind this BS, some connecting the GSK Director of Marketing to the FDA. Amarin investors should keep this in mind when an offer is made.

Williams