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A 1 Closing Remarks C. Elaine Jones, Ph.D Vice President Respiratory Regulatory Affairs.

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Presentation on theme: "A 1 Closing Remarks C. Elaine Jones, Ph.D Vice President Respiratory Regulatory Affairs."— Presentation transcript:

1 A 1 Closing Remarks C. Elaine Jones, Ph.D Vice President Respiratory Regulatory Affairs

2 A 2 Evidence of Effectiveness from a Single Study Statistically persuasive results across multiple endpoints Statistically persuasive results across multiple endpoints – Predictors of the primary endpoint of mortality Large multi-center trial Large multi-center trial – No single site or country was disproportionately responsible for the efficacy Consistent treatment effect across subgroups Consistent treatment effect across subgroups Based on strength of the data there would be ethical considerations in repeating the study Based on strength of the data there would be ethical considerations in repeating the study

3 A 3 External Experts Peter Calverley Professor of Pulmonary and Rehabilitation Medicine at the University of Liverpool, UK Honorary Consultant Physician at the University Hospital Aintree, Liverpool Paul Jones Professor of Respiratory Medicine at St. George’s, University of London Anne Whitehead Deputy Director of the Medical and Pharmaceutical Research Unit, University of Reading, UK Gary Koch Professor of Biostatistics University of North Carolina

4 A 4 Pulmonary - Allergy Drugs Advisory Committee Meeting May 1, 2007 May 1, 2007 ADVAIR DISKUS ® NDA 21-077

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