This section provides a summary of key meeting background packages submitted under IND 13408.
- EOP1 Meeting (12/18/2008): Background package provided Phase 1 safety and preliminary efficacy data and proposed a Phase 3 study design.
- Type C Meeting (09/08/2010): Package focused on the novel Multi-Luminance Mobility Test (MLMT) as the primary efficacy endpoint, including validation plans and justification.
- Pre-BLA Meeting (03/25/2016): Comprehensive package summarized the complete clinical, non-clinical, and CMC data packages. It proposed a rolling BLA submission plan and discussed the priority review status.
Full packages are available for reference in the IND archive.