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DewDiligence

08/21/11 6:46 PM

#125430 RE: Rocky3 #125427

It would be very unusual for a judge to have any idea how fast a government agency might act…

The Judge did not have to know—or guess—how quickly the FDA will act on Teva’s ANDA; rather, the Judge merely needed to estimate the minimum amount of time it could take for Teva to get FDA approval.

After seeing the FDA’s deficiency letter, the Judge probably had no difficulty ascertaining that FDA approval will not be coming before 2013.