Food and Drug Administration
July 27, 2004
Briefing Information
Eli Lilly and Company Briefing Document (PDF)
Introduction Memorandum, FDA (HTM) (PDF) (Word)
FDA Briefing Document - Clinical (HTM) (PDF) (Word)
Statistical Review and Evalution, FDA (PDF)
Corrections in FDA Clinical Briefing Materials (PDF)
Statistical Review Addendum #1 (PDF)