Cardiovascular and Renal Drugs Advisory Committee

Holiday Inn Gaithersburg

Two Montgomery Village Avenue, Gaithersburg, MD

June 16, 2005

Slides

The committee will discuss new drug applications (NDA) 20-727, proposed trade name BiDil® (hydralazine hydrochloride/isosorbide dinitrate) Tablets, (37.5 mg hydralazine hydrochloride/20 mg isosorbide dinitrate), NitroMed, Inc., proposed for the indication of heart failure, based on the results from the African American Heart Failure Trial (A-HeFT)

NitroMed Presentation

BiDil® (isosorbide dinitrate/ Manual Worcel, M.D.

hydralazine HCl): Regulatory Chief Medical Officer

Background and Introductions NitroMed, Inc.

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V-HeFT I and V-HeFT II: Jay N. Cohn, M.D.

ISDN/HYD Effects in Black Professor

Patients University of Minnesota

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A-HeFT: Rationale, Design Anne Taylor, M.D.

And Demographics Professor

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A-HeFT: Outcomes Clyde Yancy, M.D.

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University of Texas Southwestern Medical School

Conclusions: From V-HeFT I Milton Packer, M.D.

To A-HeFT Professor

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Questions and Answers Michael Sabolinski, M.D.

Senior Vice President of Clinical Development and

Regulatory Affairs

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Open Public Hearing Speakers

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Shomarka Omar Y. Keita, M.D., D.Phil.

Medical Officer

Department of Human Services, District of Columbia

Research Associate

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Basil Halliday, M.Sc.

[HTML] [PPT] President & CEO - BDH Clinical Research Services

Charles N. Rotimi, Ph.D.

National Human Genome Center

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Charmaine Royal, Ph.D.

National Human Genome Center

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Questions

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