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BioChica

06/06/16 2:42 PM

#82236 RE: HDGabor #82235

They did not used the "active ingredient" approach, but revised ingredient / moiety analysis(1 to 1 instead of 1 to many regarding AI - AM relation) during the new determination, resulted in NCE.



I thought the Judge wrote/said - The FDA must use the ingredient, rather than moity for determining NCE, as defined in Hatch-Waxman law!

I would like to see the FDA in front of this Judge again, deciding NCE case!

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FlyFishingStocks

06/06/16 2:56 PM

#82239 RE: HDGabor #82235

HD,

I agree with you that the 6 months is the conservative expectations, it is the longer end of the time curve. However, I give 0% probability to "AMRN and management is planning to surprise us as early as tomorrow".



Thus Tuesday's presentation could be defined as the ultimate deceptive "Trojan Horse" no?