FDA reviewers cited weak clinical evidence, substance-characterization concerns, differences between studied and proposed administration routes, and the availability of approved treatments for conditions discussed during the review
He L, Feng D, Guo H, Zhou Y, Li Z, Zhang K, et al
What It Is This formulation combines: AOD-9604: A growth hormone fragment studied for fat metabolism and weight management
What would move this position is: a randomised, placebo-controlled trial in a defined population with an objective primary endpoint, a pre-registered protocol, and pharmacovigilance over a clinically meaningful duration
Individuals with active cancer or recent cancer history face theoretical concerns about angiogenesis promotion