The Priority Review Voucher program will begin to sunset in September this year unless extended by US Congress.
The PRVs will be come considerably more valuable if this program is terminated. But as the law stands we also need to secure approval for bisantrene in Paediatric AML prior to September 30, 2026. I think the chances of that are probably pretty slim.
If the RPDD and PRV programs are extended I think that would be a great for RAC as I don't think we will be able to capitalise on the program otherwise.
Happy to be corrected if my interpretation of the above is incorrect.
https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/rare-pediatric-disease-designation-and-priority-review-voucher-programs
The Priority Review Voucher program will begin to sunset in...
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