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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

Patients come in having used a telehealth peptide platform for 23 months with inconsistent results

Unlike traditional blood glucose monitoring methods, CGMS offers continuous monitoring over a 24-hour period