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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

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It is speculated that the phosphorylation and possible subsequent opening of these calcium channels may allow calcium ions to enter the somatotroph cells

Lower concentrations improve precision but require larger injection volumes

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