Fig. 1

Compounding submission volume and complexity during development. The quantity of dossiers, country variants, information requests, and manufacturing changes substantially increases over time. For accelerated programs, later stages of development are often characterized by overlapping milestones and filing expectations, wherein the phase 3 trial may overlap with the filing of the marketing application. The marketing application may be filed in multiple discrete “waves” including groupings of different regions, wherein authoring, review, and approval timelines may overlap