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kaivamei

02/11/11 10:45 AM

#114567 RE: dewophile #114556

He said mC was in "after-review" at FDA.

Does anyone know what this might mean? "After-review" is not a term I am used to hearing. It almost sounds like a page out of Teva's book -- a way of saying that the main phase of review is complete, and only some bureaucratic formalities remain.

In any case, that sounded like his way of indicating that, yes, mC approval could indeed be a 2011 event.
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DewDiligence

02/11/11 12:27 PM

#114580 RE: dewophile #114556

Wheeler mentioned the lack of 180-day exclusivity for Copaxone because some sell-side analysts are confused about how the process works and erroneously stated in their reports that MNTA’s generic Copaxone was entitled to 180 days of exclusivity.

From a practical standpoint, the issue is irrelevant for the reason you mentioned.