RPD Designation Program Sunset ProvisionsOn September 30, 2020,...

RPD Designation Program Sunset ProvisionsOn September 30, 2020, Congress provided a short-term extension of the Rare Pediatric Disease Priority Review Voucher Program. According to the current statutory sunset provisions, after December 11, 2020, FDA may only award a voucher for an approved rare pediatric disease product application if the sponsor has rare pediatric disease designation for the drug, and that designation was granted by December 11, 2020. After December 11, 2022, FDA may not award any rare pediatric disease priority review vouchers.

Couple of points here:
The trials go for 12 months and 24 months, this will not be the last CR.
Without interim data the SP is not going anywhere.

They are pissing in the wind with the RPD program with a sunset clause of the 11th of December 2020. I'd say they are trying to emulate KZA's 300% increase on announcement of their RPDD. Then they have to get an NDA application in within two years to get a PRV. Potentially big bucks if they can do it but these guys are asleep at the wheel.

IMO
DYOR