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Kari Everything happened in a timely manner start to finish

While TB-500 has compelling animal data, theres almost no research performed on the peptide in humans

GLP-1 agonists produce dramatic weight loss (averaging 15-20% total body weight) primarily through central appetite suppression, eliminating hunger and creating pharmaceutical satiety

And so FDA is going to need to use a different lens. Unlike FDA approval of a new drug, which requires years of clinical trials demonstrating safety and effectiveness, placement on the 503A Bulks List answers a different regulatory question

According to USADA, the ban is in place partly because theres insufficient research on its safety and efficacy