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DewDiligence

03/07/11 5:51 PM

#116048 RE: 10nisman #116043

Start to finish, I would say one month at most.

If a bioequivalence trial is in fact being conducted, the chances are high, IMO, that NVS/MNTA is running it. (The FDA’s review of MYL’s ANDA is probably not at the stage where MYL would feel compelled to run such a study.)