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Re: Biggiee post# 54

Friday, 06/11/2021 11:26:08 AM

Friday, June 11, 2021 11:26:08 AM

Post# of 349
ORPH~~next week huge news,,

Orphazyme's applications for arimoclomol (to be branded MIPLYFFATM)1 for Niemann-Pick disease type C (NPC) are under priority review with the U.S. Food and Drug Administration, with an expected PDUFA action date of June 17 2021, as well as with the European Medicines Agency, with an opinion from the Committee for Medicinal Products for Human Use (CHMP) expected later this year.


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