Replies to post #43018 on Amarin Corp Plc (AMRN)

[epenephrine]

I have a problem with the statement.."naturally derived mixtures"......Lovasa and Vascepa are NOT naturally derived mixtures!!!!!!.....There argument has a cyclical nature to it and is flawed...They proport a weak argument to begin with and then try to validate it with the same twisted logic!!!!!....Surely Amarin's attorneys will expose this farce.....Also, are there not similiar cases where the FDA was proven wrong using this Mixture argument?.......

[ziploc_1]

ggwpq: an active moiety is the chemical that makes the drug work the way it does. For example, Erythromycin is an antibiotic which fights infection. If you mix it with an ingredient as aspirin, it would also fight infection, but Erthromycin would still be the active moiety. Lovaza is a substance including EPA,DHA, and several other molecules(ingredients). It is not any one ingredient but the combination, which makes the drug work the way it does with some good effects as lowering the trig levels and some bad effects, such as raising LDL levels. The COMBINATION is the active moiety in Lovaza, whereas, in Vascepa, the EPA is the active moiety with much different results. Therefore Vascepa should have been awarded the NCE designation.

[HDGabor]

It isn't simple at this level. This argument is valid, however the full picture is complex.

I hope the case won't reach this level and will be finished at 'ingredient' vs 'moiety' / Act vs Regulation level.

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R-IT: The company did not say any new thing. It was known that R-IT could be finished / stopped at interim. The situation is clear:
1.) eff.% is high enough (cross the stopping rule) and DMC will recommend the stop. In this case AMRN will stop the study and we will know the details.
2.) DMC will recommend to continue the study. It will be continued and we won't know any details.

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China:
It is a good - at least - as no doubt that the company has enough money till interim. I expect more details / clue at CC

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Institutional holding:
Nasdaq is wrong (some 03/31/14 is still included). Much better : whalewisdom/.
However - both - these are about 13-F. 13-G is excluded, so the % is app. 40,56% (70,977,291) w/o insiders & Mutual Fund Holders
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I will update my numbers and thoughts after the CC