Replies to post #125193 on Biotech Values

[DewDiligence]

Back in early March there was a general impression that MNTA was going to conduct a mCopaxone bio-equivalence trial small in number (<30) that may supplement their mC ANDA. That being the case, would MNTA also expect the FDA to extend an action date by three months as well for mC?

The FDA wouldn’t need to formally extend the Copaxone action date because ANDAs don’t have formal action dates in the first place.

If MNTA did in fact conduct a small bioequivalence study, it should be completed and analyzed by now (#msg-60737158).