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4SC AG Fraunhoferstr. 22 82152 Planegg-Martinsried, Germany http://www.4sc.de
Contact Mr Dr. Jason Loveridge +49 89 7007630
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4SC AG

4SC AG gibt Feedback der EMA zum Zulassungsantrag von Resminostat (Kinselby) bekannt

(PresseBox) (Planegg-Martinsried, )
Der Vorstand der 4SC AG ("4SC") (Frankfurter Wertpapierbörse, Prime Standard: VSC; ISIN: DE000A14KL72) wurde heute von der Europäischen Arzneimittelagentur (EMA) darüber informiert, dass der Antrag für Resminostat (Kinselby), ein Arzneimittel für seltene Leiden zur Behandlung von Patienten mit CTCL, nach Prüfung der endgültigen Daten und der Antworten des Unternehmens auf Fragen derzeit nicht genehmigungsfähig ist, da "schwerwiegende Einwände", sog. "Major Objections", festgestellt wurden, die die Empfehlung für die Marktzulassung zum jetzigen Zeitpunkt ausschließen (Day-180 Assessment Report).

4SC wird nun das Feedback auswerten und entscheiden, wie am besten auf die Einwände und die Liste der offenen Fragen der EMA innerhalb der Ovajyadfphiy cko kirid Xbykf zh auvtwrcjy hmz.

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The publisher indicated in each case (see company info by clicking on image/title or company info in the right-hand column) is solely responsible for the stories above, the event or job offer shown and for the image and audio material displayed. As a rule, the publisher is also the author of the texts and the attached image, audio and information material. The use of information published here is generally free of charge for personal information and editorial processing. Please clarify any copyright issues with the stated publisher before further use. In case of publication, please send a specimen copy to service@pressebox.de.