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Sam81

07/28/15 9:53 AM

#54759 RE: TortLaw #54758

Exactly my point TortLaw...that is astonishing and absolute cr&^ from the FDA. i am not that familiar with the law in the states, but this should lead to a suit reclaiming lost funds from FDA for marketing & Selling V from the adcom onwards (Marine & Anchor)
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marzan

07/28/15 11:22 AM

#54769 RE: TortLaw #54758

Then the 1A Judge is going to ask FDA to rather approve the Anchor now. Can he rule something like that instead of PI??
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rafunrafun

07/28/15 1:30 PM

#54780 RE: TortLaw #54758

The question now is, what, if anything could be done about it? If the FDA were anything other than immoral beings that they think that they are, this issue could certainly be settled in court, for either breach of contract or something something similar. But no, they are above the law, at least in their minds.
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jessellivermore

07/28/15 3:15 PM

#54790 RE: TortLaw #54758

Tort...

Yeah this has been a bone of contention since AdCom. Considering the results of Anchor in regard to lipid changes state your level of confidence that Vascepa will lower CVD risk..

Totally inappropriate question..This was used for the AdCom. vote.

":>) JL
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sts66

07/28/15 4:41 PM

#54801 RE: TortLaw #54758

Because AMRN wanted some sort of CV risk and/or use with a statin language on the ANCHOR label, IIRC?