EOP1 Meetings review several topics

• PK/PD
  • Absorption/distribution/metabolism/excretion
  • Method to determine dose to be administered
  • Planned maximum dose
  • Duration of patient exposure-Dose/response relationship
  • Initial safety analysis, unacceptable toxicities
• Proposed phase 2 protocol
• Objectives and purpose of the study
• Study design
• Subject inclusion/exclusion criteria
• Kind of control group, placebo arm
• Statistical analysis plan-Plans for crossover, early data analysis
• Endpoint selection
• Identification of populations for phase 3 trials
• Pediatric studies
• EOP2 for accelerated approval
• Adaptive trial designs
• Adequacy of supporting nonclinical data
• Proposed studies/trials to support evaluation of abuse potential
• Adequacy of data quality measures