Here's a question. If the FDA grants accelerated approval for a drug that has been granted Rare Pediatric Disease Designation when does the drug company become eligible for the pediatric Priority Review Voucher? Is it straightaway or after the successful conclusion of the Post-Approval Commitment?
It appears that the answer is straightaway. For instance, Sarepta who received accelerated approval for SRP-9001 in June 2023 sold its PRV for US$102m in July 2023.
Following the recent placement and SPP, ANP has a cash runway to Q2 2024 with the potential prospect of an accelerated approval pathway from the Phase IIb study. We can all produce our own timeline but the numbers appear to add up with ANP holding 100% of the rights to ATL1102 post approval. It makes the comparison with NEU all the more interesting particularly in regards to the potential impact upon market capitalisation.
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- Ann: Antisense Therapeutics Corporate Presentation
Ann: Antisense Therapeutics Corporate Presentation, page-59
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