Following a brief introduction by Margaret Hamburg, Commissioner of the Food and Drug Administration, the briefing will provide an overview of the clinical trials, primary efficacy,
safety, and complexity of dosing regimens. The briefing will consist of presentations by Debra Birnkrant, M.D, Director, and Jeffery Murray, Deputy Director, Division of Antiviral Products, Center for Drug Evaluation and Research (CDER), followed by an opportunity for questions from call participants.