Peripheral and Central Nervous System
Drugs Advisory Committee
Slide
Sponsor Presentations
Pozen Incorporated
Introduction and Summary Marshall
E. Reese, Ph.D.
Executive Vice President, Product
Development
Pozen Incorporated
Overview of
Tardive Dyskinesia A.H.V.
(Tony) Schapira, M.D.
Professor of Neurology,
Royal Free
Review of MT100 Efficacy William James
Alexander, M.D., M.P.H., F.A.C.P
Senior
Vice President, Clinical Development
Chief
Medical Officer
Pozen Incorporated
Potential Role of MT100 in Migraine David B. Matchar, M.D., F.A.C.P.
Therapy:
Balancing Benefits and Risks Director,
Research
Professor of Medicine
Duke University School of Medicine
Clinical Considerations on Stephen D. Silberstein, M.D.
Migraine Treatment Director,
FDA Presentations
FDA Risk/Benefit
Considerations Eric Bastings, M.D.
Clinical Team Leader, DNP, FDA
Overview of
Tardive Dyskinesia Hyder
A. Jinnah, M.D., Ph.D.
The
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