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DewDiligence

08/04/10 5:48 PM

#100743 RE: Harvey39 #100742

Why don't you ask FDA...they're the ones who signed off on [Amphastar’s] sameness.

Your definition of sameness is evidently limited to the FXa/FIIa assays. However, it’s clear from the FDA’s reply to SNY’s Citizen Petition that the FDA’s hurdle for Lovenox sameness is very much higher than that.

p.s. Your evident anger at the FDA belies your objectivity in this matter.