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Lovenox ANDA Approval In 2008 Is “Not Out Of Reach,” Momenta CEO Wheeler Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Chief exec optimistic that FDA will not require any additional clinical trials to move filing forward.

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FDA Cites Immunogenicity Concerns In “Not Approvable” Letter For Momenta/Sandoz’s Lovenox Generic

Firm is “confident” no immunogenicity differences will arise, Momenta CEO Wheeler says.

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