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It is alleged in this complaint that Orphazyme made misleading and false statements to the market. Orphazyme’s arimoclomol was not an effective treatment for Inclusion Body Myositis (“IBM”). Additionally, Arimoclomol was not an effective treatment for Amyotrophic Lateral Sclerosis (“ALS”). Orphazyme’s new drug application (“NDA”) for arimoclomol for the treatment of Niemann-Pick disease type C (“NPC”) was incomplete and require∂ additional data to support its benefit-risk analysis. It was not likely that The FDA would approve the Orphazyme’s NDA for arimoclomol. Orphazyme’s public statements were false and materially misleading throughout the class period, based on these facts. Investors suffered damages when the market learned the truth about Orphazyme.