Yes, any RPD voucher granted could be used by PYC to fast track FDA review of a second drug, and that could be any drug. It would be a matter of calculating where the most value lies – in its saleable value or in shaving 4 months off FDA review time. Typically, an RPD voucher gets used when a drug sponsor with a potential blockbuster drug wants to beat a rival drug to the approval line.
But at this stage, it’s all hypothetical. Any voucher wouldn’t be received until drug approval. For VP-001, H2 2025 is the absolute earliest that could happen, by my estimation. Further, PYC can only be in the running for RPD if the Creating Hope Reauthorization Act is passed by Congress and that’s not a given. Finally, although I don’t think there can be any dispute that RP11 qualifies as a rare disease, meeting the second criterion for RPD (manifestation of serious or life-threatening symptoms before the age of 18) isn’t so clear-cut, in my view.
PYC Price at posting:
17.5¢ Sentiment: Hold Disclosure: Held
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