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It doesn't. A successful NDA (new drug application) is what is...

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    It doesn't. A successful NDA (new drug application) is what is required.

    Edit: Excludes off label, extended clinical use. OD is just to incentivise companies to target rare diseases. Autism does not quality, but Rett Syndrome does for example.
    Last edited by htae39: 23/07/24
 
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