If the results of the Phase 3 trial are positive, a New Drug Application is approved by the FDA and trofinetide is launched in the US, Neuren would earn revenue over 2022 and 2023 for Rett syndrome in the US alone of A$111 million plus double-digit percentage royalties on net sales. This assumes a USD/AUD exchange rate of 0.75 and that Neuren receives US$33 million as its share of the market value of a Rare Pediatric Disease Priority Review Voucher awarded on approval of a New Drug Application.
Finally, we have an answer to one of our questions at the time of the announcement of NEU’s deal with Acadia.
Of the US$105m development milestone payments on offer, US$50m applies to trofinetide in Rett syndrome.
My guess is that the US$50m will be broken down into two milestone payments – one payable on any NDA submission and the other on FDA approval.
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