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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

The TKT gene is located on chromosome 3p21.1 and is composed of 15 exons that generate three alternatively spliced mRNAs that collectively encode two distinct protein isoforms

the results are expected to be reported in 2025

Results demonstrated a remarkable 4.4kg decrease observed within just four weeks of treatment

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