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Giles FJ, Cortes JE, Bivins C, Andreeff M , Talpaz M, Jolivet J, Kantarjian HM

Research has explored its influence on growth hormone signaling pathways, with interest in its receptor specificity and minimal activity at other endocrine receptors when examined under controlled laboratory conditions

Mutations can occur in somatic cells or germ cells (sperm or egg)

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

Both medications affect similar hormone pathways that control appetite, digestion, and blood sugar