Flawed Junovan Trial Design Leads Committee To Doubt Efficacy Results
Executive Summary
Problems in clinical trial design for IDM Pharma's osteosarcoma drug Junovan (mifamurtide) could have been rectified if the sponsor had held an end-of-Phase II meeting with FDA prior to study initiation, the agency said in briefing documents for a May 9 meeting of the Oncologic Drugs Advisory Committee