Excellent! Hence why SYC is targeting cancers of unmet needs! Its the quickest and least expensive route to commercialisation.
"The benefits of an Orphan Drug Designation are considerable and include guaranteed market exclusivity of seven years from granting of regulatory approval; and a waiver of Prescription Drug User Fee Act (PDUFA) fees for orphan drugs, which has a value of over US$3.1 million in 2021."
Ann: US FDA Grants Orphan Drug Designation to PTX-100 for PTCL, page-6
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