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
You may also be interested in...
Secondary Endpoints, Post Hoc Data May Be “Sweet Spot” For Payers
ATLANTA - Companies should look for the types of clinical trial data which may not be sufficient alone for FDA approval, but could be persuasive to payers making coverage determinations, Schering-Plough's David S. Sugano suggests
Secondary Endpoints, Post Hoc Data May Be “Sweet Spot” For Payers
ATLANTA - Companies should look for the types of clinical trial data which may not be sufficient alone for FDA approval, but could be persuasive to payers making coverage determinations, Schering-Plough's David S. Sugano suggests
End Of Phase II Meetings Used By Less Than Half The Firms In PwC Survey
Fewer than half of drug companies participating in a PricewaterhouseCoopers survey participated in a meeting with FDA at the conclusion of Phase II studies