Peripheral and Central Nervous System Drugs Advisory Committee
Introduction and Summary Marshall E. Reese, Ph.D.
Executive Vice President, Product Development
Overview of Tardive Dyskinesia A.H.V. (Tony) Schapira, M.D.
Professor of Neurology,
Review of MT100 Efficacy William James Alexander, M.D., M.P.H., F.A.C.P
Senior Vice President, Clinical Development
Chief Medical Officer
Potential Role of MT100 in Migraine David B. Matchar, M.D., F.A.C.P.
Balancing Benefits and Risks Director,
Professor of Medicine
Duke University School of Medicine
Clinical Considerations on Stephen D. Silberstein, M.D.
Migraine Treatment Director,
FDA Risk/Benefit Considerations Eric Bastings, M.D.
Clinical Team Leader, DNP, FDA
Overview of Tardive Dyskinesia Hyder A. Jinnah, M.D., Ph.D.
Post-marketing Review of Movement Mary Ross Southworth, Pharm.D.
Disorders and Neuroleptic Malignant Safety Evaluator, Division of Drug Risk Syndrome
Associated with Metoclopramide Evaluation, Office of Drug Safety, FDA
Questions from the Committee to the Sponsor and FDA