2023 The Final Countdown, page-2994

With the high mortality rate of paediatric patients with sr-GVHD I wonder if Mesoblast will qualify for a Priority Review Voucher if the FDA approve Remestemcel-L ?


https://www.fda.gov/industry/medica...-disease-rpd-designation-and-voucher-programs

Rare Pediatric Disease (RPD) Designation and Voucher Programs

06/02/2023


Under Section 529 to the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA will award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. Under this program, a sponsor who receives an approval for a drug or biologic for a "rare pediatric disease" may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product.