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Novo detemir approval timeline

Executive Summary

Novo-Nordisk expects mid-2005 approval for long-acting insulin analog detemir following submission of additional data to FDA, CEO Lars Rebien Sorensen says. FDA requested more clinical information in Oct. 7 "approvable letter" (1"The Pink Sheet" Oct. 13, 2003, In Brief). Novo believes the request can be met through a "short-term" PK/PD study to assess ethnic differences between patients and data from an ongoing trial...

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