This article might be an interesting read for the expert Paradigmers amongst you...or for anyone that would like to know a bit more about the joint U.S. Food and Drug Administration (FDA) / European Medicines Agency (EMA) application that Paradigm are in the process of making.
The FDA / EMA published a joint report on their efforts to support the development of and expedite access to breakthrough therapies that address unmet medical needs.
https://www.lexology.com/library/detail.aspx?g=85676a2f-f75a-43a7-8acc-8abf817a48e5
Good luck to all, Paradigmer as the news unfolds over the coming months
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