Table of Contents
Zometa for Patients with Bone Metastases
FDA Clinical Review Team
Outline of Presentation
Proposed Zometa Indication
Efficacy requirement
FDA-Applicant Design Assumptions
SRE Analyses
SRE Analyses
Critical Questions Myeloma and Breast Cancer
Critical Questions Prostate Cancer (Study 039)
Critical Questions Other Solid Tumors (Study 011)
Study 010 Design
Study 010 Design
PPT Slide
PPT Slide
Determing Zometa Effect
Constancy Assumption
Differences Between Historical Population and NDA Population
Evaluating Assumption (1)
Evaluating Assumption (2)
Evaluating Assumption (3)
Myeloma And Breast Cancer FDA Conclusion
PPT Slide
Questions to ODAC
Critical Questions: Myeloma and Breast Cancer
Critical Questions Prostate Cancer (Study 039)
Critical Questions Other Solid Tumors (Study 011)
Efficacy requirement
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