Orphazyme: Focus remains on path to regulatory approval for arimoclomol in Europe and the USA - Redeye
Orphazyme remains committed to pursuing a path to regulatory approval in Europe and the United States, for arimoclomol in NPC despite a Complete Response Letter from FDA. It could prove to be difficult as a likely outcome would be request for more clinical data which would call for financing combined with the fact that it is difficult to find patients for a large study.
Länk till analysen i sin helhet: https://www.redeye.se/research/819952/orphazyme-q221-focus-remains-on-path-to-regulatory-approval-for-arimoclomol-in-europe-and-the-usa?utm_source=finwire&utm_medium=RSS