Thanks again to you.
everything seems to confirm that Neuren won't be around long as an entity, but will indulge handsomely soon.the ROW issue and the method by which it would be addressed in the event of an approval for RETT by the FDA had already been decided in 2015. already at the time work was underway to guarantee to whom the rights would be sold, to provide a package as valuable as possible. the real goal with EMA was to guarantee exclusivity and a lot of time to better manage Trofinetide. Neuren was of little interest at the time and nothing today when and how much Trofinetide would have been able to intercept capital. everything has always been done to have the highest possible bargaining power once the marketing goal in the USA is reached. Below is the content of an official press release from Neuren on the matter:
Melbourne, Australia, 29 July 2015: Neuren Pharmaceuticals (ASX: NEU) today reported important
progress in its development programs for trofinetide in Rett syndrome and Fragile X syndrome.
The Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has
recommended that Orphan designation be granted for trofinetide in both Rett syndrome and Fragile X
syndrome. Neuren anticipates that the European Commission will provide formal confirmation of these
designations in August 2015.
Orphan designation in the European Union (EU) enables sponsors to benefit from a number of
incentives, including 10 years of market exclusivity once the medicine is on the market. During that
exclusivity period, the EMA and the EU Member States shall not accept another application for a
marketing authorisation, for the same therapeutic indication, in respect of a similar medicinal product.
Neuren’s programs for Rett syndrome and Fragile X syndrome have previously been granted Orphan
Drug designation by the US Food and Drug Administration (FDA), which provides 7 years of market
exclusivity in the United States
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Thanks again to you.everything seems to confirm that Neuren...
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