1	Advisory Committee Discussion Points
2	Questions 1. Do the safety and efficacy data presented support accelerated approval of maraviroc for treatment-experienced HIV-1 infected patients with CCR5-tropic virus? If not, please discuss what additional data are needed to provide sufficient evidence of efficacy and safety. If so, please comment on additional data (e.g., patient subgroups, longer term follow-up, etc.) that Pfizer should provide post-marketing to further characterize the safety and efficacy profile of maraviroc
3	Questions 2. There have been several safety concerns during the development of all CCR5 co-receptor antagonists, including risk of lymphomas and infection, hepatotoxicity, and tropism switching. Please discuss each of these issues with respect to maraviroc specifically, and provide recommendations for possible product labeling, post-marketing studies or post-marketing risk management strategies.
4	Questions 3. Do the data support the Applicant’s proposed dosing? Please consider the recommended dose in light of the exposure-response modeling.
5	Questions 4. The Monogram Trofile assay was used to screen subjects for enrollment and to monitor subjects for tropism switching. Please discuss how you would recommend assays for tropism testing be used for the management of subjects who might receive maraviroc in clinical practice.
6	Questions Please discuss the impact of the availability of maraviroc on the design of future Phase 3 trials for new antiretroviral agents in the treatment-experienced population and provide recommendations for how those trials should be designed accordingly.