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DewDiligence

08/06/15 11:07 AM

#194121 RE: DewDiligence #194119

(MNTA)—Confirmed on today’s MYL CC that FDA recently sent MYL a list of questions about the Copaxone ANDA and that MYL has not yet replied (although they say they plan to reply soon).

Sounds like MYL is at least a year away from potential FDA approval.