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We generated the R206A mutant variant, but this mutation leads to highly unstable protein

This was Citius second try for FDA approval, after the regulator rejected Lymphir in July 2023, outlining the need for enhanced product resting requirements. In its resubmitted data package, the company included findings from the from the Phase III Study 302 trial, where treatment with the drug led to an objective response rate of 36.2%, with 8.7% reaching complete response

Due to the potential for soy isoflavone supplements (which may contain higher concentrations of isoflavones than found in food) may affect certain hormones, including estradiol and thyroid hormones, and therefore are generally not recommended for pregnant or nursing women (Franke, Am J Clin Nutr 2006