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Re: DewDiligence post# 54622

Friday, 11/09/2007 8:31:45 PM

Friday, November 09, 2007 8:31:45 PM

Post# of 257580
MNTA: Recap

M118 uses the heparinases and purifies active fractions or better yet once they know the active fractions they chemically synthesize them. Better activity and pharmacokinetics than Lovenox. I can see from the PNAS paper why interest in high in this version.

Versus M-Enoxaparin which uses chemical synthesis and chemical cleavage to produce a Lovenox equivalent. Two other ANDAs outstanding. All are likely to require immunogenicity data to get FDA approval.

Was MNTA furthest along in the FDA process of the three generics?

Thanks Dew. Very educational.

Cheers
DAK

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