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Re: dav1234 post# 116486

Tuesday, 03/15/2011 9:19:42 PM

Tuesday, March 15, 2011 9:19:42 PM

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…is it plausible that the FDA is waiting for clarity on patent issue before issuing a decision on M-Copax or would that normally not have any bearing on their review?

The patent case has no bearing on when the FDA acts on the Copaxone ANDA. Note that the 30-month Hatch-Waxman stay on final FDA approval has already expired.

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