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Advair Survival Claim In Question; Data Not Robust, But Can’t Confirm – Cmte.

Executive Summary

In reaching a decision about whether to approve a survival claim GlaxoSmithKline's Advair,FDA will have to weigh the Pulmonary-Allergy Drugs Advisory Committee's concerns about the robustness of the findings of the single trial that has been conducted with the panel's predictions that it may be impossible to conduct a confirmatory survival study
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