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jb_118

04/28/11 11:18 PM

#119073 RE: DewDiligence #119063

It’s excellent news for MNTA investors that an FDA staffer cites MNTA’s generic Lovenox as the impetus for the FDA’s going “one step further” than the EMA is enabling biogenerics.



Agree. I've always wondered where the ceiling is going to be for MNTA's technology, where the entity is complex enough that clinical trials are required despite MNTA's best efforts. The suggestion that the tech might be relevant to FOB w/o trials is excellent news, both in that space and more proximately it also bodes well for m-copaxone. Although mC is in a different class, it can't be more difficult to characterize than a biologic. Could be wrong, but that the FDA is thinking of using it in FOB areas suggests it hasn't hit it's ceiling with mC.

Edit: looks like pcrutch had the same thought before me.