The PRV program is an incentive for companies to invest in new drugs for underserved patient populations through the granting of transferable vouchers. Once issued, a PRV can be used by its holder to accelerate the review of subsequent drug submission and reduce NDA review time to as little as six months. Voucher eligible programs include
Appili believes that ATI-1701 and ATI-1801 may be eligible for a priority review voucher PRV, if approved by the FDA. Once issued, a PRV can be used by its holder to accelerate the review of a subsequent drug submission. PRVs are transferrable and the secondary market for PRVs is well established with over 20 transactions reported publicly and recent transactions often exceeding US$100 million.
The U.S. Congress passed the 21st Century Cures Act to: