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It is alleged in this complaint that CorMedix made misleading and false statements to the market. CorMedix suffered from deficiencies in relation to DefenCath’s manufacturing process. Based on these deficiencies, it was unlikely that the FDA would approve CorMedix’ NDA for DefenCath. The Company downplayed the extent of these manufacturing problems in its public statements. CorMedix’ public statements were materially misleading and false throughout the class period, based on these facts. Investors suffered damages when the market learned the truth about CorMedix.