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Replidyne Seeks Another Partner Before Conducting New Phase III Orapem Studies

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA requests four additional studies to reconsider a new NDA for antibiotic candidate that was previously deemed “not approvable.”

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Firm will not make a commitment to pursuing a Phase III trial for the antibiotic until a second-quarter meeting with FDA.

Replidyne Seeks New Partner For Orapem After Forest Backs Out Of Development

Replidyne said its top priority will be clarifying the regulatory approval process for community antibiotics with FDA.

Forest’s Faropenem Is “Not Approvable”; Additional Studies Will Take Two Years

FDA decision reflects the agency's new position on the need for superiority studies to support the approval of antibiotics, Replidyne says.

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