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NEU $1.19

EMA Application

  1. Bloody Nine

    18 Posts.

    Hi all - great news on orphan drug granted by FDA, let's keep jumping those hurdles Neuren.....
    I have also found the following - the application for orphan drug to the European Medicines Agency is particularly of interest to me and cant remember reading this in any other announcement:-

    Neuren (NEU) - ASX Announcement 16 February 2015 Neuren receives Orphan Drug designation from FDA for trofinetide in Rett syndrome Melbourne, Australia, 16 February 2015: Neuren Pharmaceuticals (ASX: NEU) today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug designation to Neuren's drug trofinetide for treatment of Rett syndrome.
    Orphan Drug designation is a special status that the FDA may grant a drug intended to treat a rare disease or condition. Orphan Drug designation qualifies the sponsor of the drug for 7 years of marketing exclusivity following marketing authorisation. The FDA granted Orphan Drug designation to Neuren for trofinetide in Fragile X syndrome in October 2013.
    Neuren has commenced the process of Orphan Drug applications to the European Medicines Agency for trofinetide in both Rett syndrome and Fragile X syndrome. Orphan Drug designation in the European Union qualifies the sponsor of the drug for 10 years of marketing exclusivity following marketing authorisation.

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