Wait what? The way I read this, is that the FDA can issue another Voucher?
Trofinetide has been granted Fast Track Status and Orphan Drug Designation for the treatment of Rett syndrome in the United States. An NDA with Orphan Drug Designation is eligible for priority review. Trofinetide has also been granted Rare Pediatric Disease (RPD) designation by the FDA. With such designation, Acadia expects to be awarded a Priority Review Voucher if the NDA is approved.
Why would they type "to be awareded a Priority Review Voucher"? I thought they already have one for Trofinetide?
Wait what? The way I read this, is that the FDA can issue...
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