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The commenters stated that the cost of the procedure is approximately $350 to $360 and therefore the proposed payment rate of $61.00 falls far short of adequate reimbursement and threatens patient access to the procedure

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Safety Profile and Realistic Risk Assessment GHK-Cu demonstrates a generally favorable safety profile based on over 40 years of research, though most safety data derives from topical applications and animal studies

Research Findings The research history of AOD9604 spans multiple phases of preclinical and clinical development, with generally positive findings regarding efficacy for body fat reduction and favorable safety compared to growth hormone, though ultimate regulatory approval has remained elusive