NEU neuren pharmaceuticals limited

Ann: Acadia submits Rett Syndrome New Drug Application to the FDA, page-18

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    No guarantee of either, but the odds are pretty goood.

    Likelihood of FDA acceptance of an NDA for filing - 93.8%

    https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2775955


    Likelihood of FDA marketing approval for orphan drug NDA - 93.6%

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    Biotechnology Innovation Organization (BIO): David Thomas; Informa Pharma Intelligence: Daniel Chancellor, Amanda Micklus, Sara LaFever, Michael Hay; QLS: Shomesh Chaudhuri, Robert Bowden, Andrew W. Lo (2021) Clinical Development Success Rates and Contributing Factors 2011–2020
 
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