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.
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With the high mortality rate of paediatric patients with sr-GVHD...
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