What do Orphan Drug Designation and Fast Track designation mean for Saltikva?

The FDA lists Orphan Drug Designations for Saltikva's active ingredient in pancreatic cancer (2022) and osteosarcoma (2025). Orphan Drug Designation is given to products for rare diseases and offers development incentives, and Saltikva also has Fast Track status, which is meant to speed development and review. Neither designation means that Saltikva is approved or has been shown to work.