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1	QUESTIONS TO THE COMMITTEE 1. Do data from the pivotal study provide substantial evidence of safety and efficacy of daptomycin in the treatment of S. aureus bacteremia? Please include in your deliberations a discussion of the significance of patients with persistent or relapsing bacteremias, and whose staphylococcal isolates had increasing MICs to daptomycin. a. If your response is yes, are there specific comments that you have regarding the product label? b. If your response is no what additional study or studies would you recommend?
2	QUESTIONS TO THE COMMITTEE (Continued) 2. Do data from this study provide substantial evidence of safety and efficacy of daptomycin in the treatment of patients with infective endocarditis? Please include in your deliberations a discussion of whether the efficacy results in the all-comers population with S. aureus bacteremia can be extrapolated to the subgroup with infective endocarditis.
3	QUESTIONS TO THE COMMITTEE (Continued) 3. Do you recommend additional studies of daptomycin in the treatment of patients with S. aureus bacteremia, including infective endocarditis? 4. What recommendations do you have for future studies of S. aureus bacteremia and endocarditis? Please include in your discussion study design issues such as case definition, specificity of diagnosis at baseline, inclusion and exclusion criteria, and endpoints.