Actually, they stop awarding RPDD PRVs next year. Companies which are awarded the designation before that have an additional 2 years to get FDA registration to be awarded the PRV.
Still, that's impossible for AGN. Even if they managed to get the nod for a phase1a/1b followed by a registrational phase 2, it will be at least the end of the decade before the drug is approved in HIE.
Might still be worth applying in the off-chance that the RPDD PRV program keeps getting extended. But unlikely.
.
Ann: Preclinical HIE Study - ARG007 Effective Stand-Alone Therapy, page-14
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