To be clear, to be eligible for a Priority Review Voucher (which is awarded at the discretion of the FDA at the time of drug approval), a drug must first have been granted Rare Paediatric Disease Designation (as PYC- 001 for ADOA already has).
The PRV program is specifically intended to incentivise the development of drugs for rare disease in the paediatric population.
While PYC’s VP-001 in RP11 SAD trial was restricted to the 18+ age population, I note that the MAD trial is also open to the 12-18 yr age group.
The Priority Review Voucher Program is still in limbo. Due to the US federal election, the expiry date for the program has been pushed back from September to December. The House of Representatives has already voted in favour of extension of the program until 2028 but the Senate needs to agree as well by December.
PYC Price at posting:
20.0¢ Sentiment: Hold Disclosure: Held
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