Anavex Life Sciences Corp (AVXL)

[Mikesc]

Phase 2: Limited, controlled clinical studies
Study Objectives during the different
IND Phases

– Closely monitored, usually several hundred subjects
– To obtain preliminary data on effectiveness of the drug
– To determine common short-term side effects and risks

• Phase 3: Expanded, controlled and uncontrolled trials

– Usually several hundred to several thousand subjects
– To gather additional effectiveness and safety information
– To provide an adequate basis for extrapolating results to general
population and in supporting that information in the labeling

The old way... the new way should be more adaptive.