This section contains a log of official meeting minutes and key correspondence with the Agency.
- EOP1 Meeting Minutes: Document the agency's feedback on the initial Phase 3 design.
- Type C Meeting Minutes (2010, 2012): Chronicle the iterative development of the MLMT endpoint, reflecting recommendations from both CDER and CDRH on the mobility test protocol. This includes FDA feedback recommending further revisions and an AI letter.
- Type C Meeting Minutes (June 15, 2015): Document FDA's recommendation for co-primary endpoints (MLMT score change using both eyes and using the first-treated eye) and the use of the ITT population for the primary analysis.