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Re: 10nisman post# 116043

Monday, 03/07/2011 5:51:21 PM

Monday, March 07, 2011 5:51:21 PM

Post# of 257253
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.)

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