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Re: jbog post# 17811

Thursday, 10/12/2017 3:17:11 PM

Thursday, October 12, 2017 3:17:11 PM

Post# of 20689
jbog do you know when does FDA reinspect a plant after the warning letter? I kinda feel the inspection has been done, but pfzier failed the inspection again. Therefore, FDA had no choice but to approve Mylan's copaxone first. I looked into Mylan's conference transcript. Apparently, Mylan stated it was FDA administration issues causing the delay and there was no outstanding scientific issues with their copaxone . I suspect FDA was waiting for the result of the re-inspection hoping to approve MNTA and Mylan copaxone at the same time.