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Re: gfp927z post# 54618

Friday, 11/09/2007 7:56:07 PM

Friday, November 09, 2007 7:56:07 PM

Post# of 257644
>MNTA – If the FDA has nixed two other generic Lovenox approvals, why should Momenta's be any different?<

As of three days ago, both of those other ANDA’s were presumably still open. What their status is now is unclear; however, if they have been rejected, that’s a good thing, not a bad thing, for MNTA.

Why? Because the economic terms of MNTA’s Lovenox collaboration with Sandoz are more favorable for MNTA if the Teva and Amphastar ANDA’s fail.

>Isn't the FDA just continuing its established pattern of shooting down attempts at a generic Lovenox?<

Where is there a pattern? The first FDA action on any of these ANDA’s was presumably just three days ago.

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