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KCSVEN

07/25/13 11:49 AM

#11207 RE: Biobillionair #11204

I believe that is in relation to draft guidance for generics. It seems AMRN wants the guidance to state it must be pure EPA, that anything else in it in more than trace amounts, DHA etc...makes it not generic Vascepa.

This is pretty smart obviously because it makes generics run right into AMRN's patent defense if they are unable to use more filler.

Though some of it can be used for NCE argument it's main arguments solely relate to trying to sway the FDA in terms of what they put out to generics.