Allos Oncologic Efaproxiral “Approvable” Pending Phase III ENRICH Data
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA followed the recommendations of its Oncology Drugs Advisory Committee in issuing an “approvable” letter. Efaproxiral approval is also conditional on FDA clearance of Allos’ manufacturing facility and forthcoming agency comments on pharmacology, toxicology and chemistry issues.