BOEHRINGER MANNHEIM RETEPLASE MEETS FDA THROMBOLYTIC EFFICACY STANDARD, ADVISORY COMMITTEE AGREES; THROMBOLYTIC CLINICAL TRIAL DESIGNS REVISITED
Executive Summary
Boehringer Mannheim's reteplase trials meet FDA's standard of assuring that at least 50% of the mortality benefit of approved thrombolytics is preserved, FDA's Cardiovascular & Renal Drugs Advisory Committee concluded May 3.