Replies to post #17811 on Momenta Pharmaceuticals, Inc. (MNTA)

[tony111]

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.