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Ann: Phase II/III autism trial shows further benefits, page-12

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    OD designation doesn't provide any revenue. There are other benefits in reducing the overall time to get an outcome from the FDA. If a PRV is granted that has a $ figure (about 100m USD) but those are granted only after a successful NDA in the US. The PRV is worth approximately that value, given recent sales. As a point of comparison Acadia is sitting on a PRV and NEU is entitled to 1/3 of its value (33m AUD) but NEU will also get another PRV for NNZ-2591 for Phelan McDermid Syndrome if they are ultimately successful with Phase 3.

    None of this is applicable to TGA/Australian approval.
    Last edited by htae39: 22/07/24
 
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