Ann: Strategic Partnership and Lead Program, page-34

I’ve mentioned this before: PYC is unlikely to be able to benefit from the paediatric rare disease priority review voucher program.

Only drugs already designated as rare paediatric treatments and which receive marketing approval by October 2022 can receive a voucher.

Suffice to say, there is no way that PYC/Vision would be able to file an NDA prior to October 2022, yet alone receive marketing approval.

As it stands, the only possible way that PYC/Vision could receive a Priority Review Voucher is if the US Congress legislates to extend the program.

https://www.fda.gov/media/90014/download


Re use of the platform beyond eye disease, the presentation put out a month ago specifies neurodegenerative disease, genetic liver disease and an oncology target.