Phase II Pediatric Results A Boost For Replidyne’s Faropenem
This article was originally published in The Pink Sheet Daily
Executive Summary
Firm will not make a commitment to pursuing a Phase III trial for the antibiotic until a second-quarter meeting with FDA.
You may also be interested in...
Replidyne Seeks Another Partner Before Conducting New Phase III Orapem Studies
FDA requests four additional studies to reconsider a new NDA for antibiotic candidate that was previously deemed “not approvable.”
Replidyne Seeks Another Partner Before Conducting New Phase III Orapem Studies
FDA requests four additional studies to reconsider a new NDA for antibiotic candidate that was previously deemed “not approvable.”
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.