 Shares of Orphazyme AS plummeted 54.3 in premarket trading Friday, after the Denmark-based biopharmaceutical company said overnight that it received a Complete Response Letter CRL from the U.S. Food and Drug Administration regarding its treatment for Niemann-Pick disease type C NPC. The CRL said additional qualitative and quantitative evidence was needed to substantiate the validity and interpretation of the 5-domain NPC Clinical Severity Scale and the swallow domain, as well as additional data to confirm evidence beyond the single Phase 23 trial supporting the benefit-risk assessment of the New Drug Application NDA. 