GENENTECH ACTIVASE FDA ADVISORY COMMITTEE REVIEW IN JUNE
GENENTECH ACTIVASE FDA ADVISORY COMMITTEE REVIEW IN JUNE may be scheduled to discuss the results of the GUSTO-1 trial that showed a 1% absolute difference in mortality between an accelerated Activase (alteplase or tPA) regimen and streptokinase in heart attack patients. FDA's Cardiovascular & Renal Drags Advisory Committee is tentatively scheduled to meet June 9-10 and is expected to consider the supplemental PLA for a change in dosing regimen filed by Genentech based on data from the 41,000- patient GUSTO-1 trial first reported in April 1993 ("The Pink Sheet" May 3, 1993, T&G-3).
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