Ventrus Reports Positive Phase III, But Warns Again That FDA May Want Second Study
This article was originally published in The Pink Sheet Daily
Executive Summary
After announcing positive results from a Phase III European study of topical diltiazem for anal fissures, Ventrus cautions that a new study including Americans may be needed for FDA approval. The company says that if it gains approval, it may price the therapy on a par with recently cleared Rectiv from ProLactan.