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Once the ovaries become redundant, changes in the levels of oestrogen and progesterone disturb information being relayed to and from the pituitary gland, which causes levels of GnRH (gonadotropin-releasing hormone), FSH (follicle stimulating hormone) and LH (luteinizing hormone) to rise

Testes were surgically removed, and animals were placed individually in new clean cages after surgery, monitored twice a day for 710 days for recovery until suture clips were removed under brief isoflurane anesthesia

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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