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DewDiligence

02/18/11 1:59 PM

#115111 RE: dewophile #115110

MNTA does not appear to be taking the Gad litigation seriously, which suggests that MNTA knows its workaround for measuring molecular weight is non-infringing and the FDA is already on board with the workaround method.
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DewDiligence

03/02/11 8:20 PM

#115767 RE: dewophile #115110

Re: Gad patents and timing of Copaxone ANDA review

…it sounds as if MNTA needs to submit an [ANDA] amendment. the fact management does not think this will be rate-limiting in approval tells me copaxone approval is at the earliest a late 2011 event.

Already done, according to Rick Shea on today’s RBC webcast. Hence, I think your inference vis-à-vis the timing of FDA approval is no longer valid.