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A., Quick, A., Wymer, J., Goutman, S

Glucose-6-phosphate dehydrogenase (G6PD)-deficient infants: enzyme activity and gene variants as risk factors for phototherapy in the first week of life

These changes were associated with widespread synaptic degeneration in both species (Marsan et al., 2023)

(2015) 37:9961009.e7

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

Mid-range doses (10-20mg) showed optimal efficacy-to-safety ratio Phase III: ~500 subjects, 24 weeks, failed to reach primary endpoint (statistically significant weight loss vs placebo at 24 weeks)