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The (therapeutic) target(s) may be a single gene, locus, or other genomic site, or may be multiple genes, loci or other genomic sites

FDA staff's own briefing document, posted publicly ahead of the meeting as part of the docket, proposes that TB-500 (free base) and TB-500 acetate not be added to the list, citing incomplete physicochemical characterization, a lack of evidence of effectiveness for wound healing (including an in-vitro fibroblast study in which TB-500 reportedly did not induce wound healing), and insufficient nonclinical and clinical safety data

2021, pp

Each of these compounds has unique characteristics that affect its efficacy, selectivity, and overall benefits for patients seeking to optimize their hormones and body composition

bis(4,4-bis(decyloxy)butanoate) (CY67) Prepared following Procedure E described in Compound CY63 synthesis

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