Published in Vaccine Weekly, October 3rd, 2001
Primary results from the trial will form the foundation of the Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for marketing approval of OvaRex monoclonal antibody (MAb). Submission of the BLA is expected by year end 2001 or early in 2002, assuming the timely scale-up of cell culture manufacturing to establish product comparability.
With the patient treatment now complete for this lead trial, an Endpoint...
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