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louieblouie

08/19/15 11:45 AM

#56895 RE: ziploc_1 #56893

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.