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jessellivermore

10/05/15 8:54 AM

#60633 RE: north40000 #60630

North...

I also do not understand your argument.

Amarin's "promotions" do not include statements like R-I has shown V lowers CVD risk...statements which would require a positive result from the trial..What they include are results of completed trials..eg.JELIS, as well as clinical, physiological, and epidemiological information that supports the utility of EPA (Vascepa) in adequate dosage to lower CVD risk.

Holding off until the R-I results are known is a terrible idea.

":>) JL

TortLaw

10/05/15 9:21 AM

#60636 RE: north40000 #60630

I hope that Amrin's counsel will insist on the inclusion of language from the FDA that makes the terms "truthful" and "non-misleading" less elastic than the broad, amorphous interpretations that FDA would certainly attempt to apply if left to their own devices.

The problem, as I view it, is not at all a case of Amarin trying to hoodwink Doctors, the problem is in defining what, exactly, is the criteria that FDA will apply when determining if a statement is truthful? Unless language is crafted that more precisely defines the parameters and criteria that will be applied, I think it very likely that FDA will be endlessly "picking fly-shit out of pepper" in it's vindictive retribution of Amarin.

There is little question in my mind that FDA has a big axe to grind with Amarin, in fact, I doubt there is a solitary reader of this board, Long or Short, that does not acknowledge bad blood between the FDA and Amarin. The FDA has routinely shown themselves to be an extremely self-serving agency in terms of protecting their near imperial power...even if protecting that power includes their use of non-truthful, misleading statements or trampling on U.S. Constitution. Make no mistake, the FDA are indeed bad actors.