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Re: ziploc_1 post# 56893

Wednesday, 08/19/2015 11:45:02 AM

Wednesday, August 19, 2015 11:45:02 AM

Post# of 447606
one would think - but if this has never happened before (where the FDA doesnt decide on exclusivity on the date the drug is approved as in the case of AMRN....or perhaps even during the exclusivity period which could occur) and its not clearly outlined in the regulations - then it may well boil down to the court coming up with the decision as to when exclusivity expires - which sets the precident in the absence of law or regulation.

Mind you - I'm guessing.
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