Yep, agree we will never get to use - except in partnership post FDA approval (assuming exit after P2 does not occur). It would be a sweetener for Pharma especially if they want it for another one of their projects.
Also the PRV has effectively been canned with sunsetting rules. A PRV can only be granted to a designated rare pediatric disease that was granted before 30/09/2024. Plus, No PRV can be granted post 30 September 2026, so limited timeframe to be of any use.
General Comments / Chat, page-5382
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