Catalyst

Slingshot members are tracking this event:

Amryt's (AMYT) FILSUVEZ (Oleogel-S10) for Epidermolysis Bullosa PDUFA extended 3 months to February 28, 2022 - Received CRL

Source Link:
https://otp.investis.com/clients/uk/amryt_pharmaceuticals_dac1/rns/regulatory-story.aspx?cid=1375&newsid=1480844

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Additional Information

Clinical Data Update on 23 Nov 2021: Initial date under priority review set for November 30, 2021, was extended 3 months to February 28, 2022
https://otp.investis...
Additional Relevant Details Update on 28 Feb 2022: Amryt Pharma: FDA says cannot approve Oleogel-S10 NDA in current form
https://otp.tools.in...
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Catalyst Date
Occurred on:
Feb 28, 2022
Occurred Source:
https://otp.tools.investis.com/clients/uk/amryt_pharmaceuticals_dac1/usn/usnews-story.aspx?cid=1375&newsid=81548
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Related Keywords Filsuvez, Oleogel-s10, Epidermolysis Bullosa
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