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clinical studies in children noted a small percentage of patients developed hypothyroidism during GH/GHRH therapy and required thyroid hormone replacement

Sikiric, P., Drmic, D., Sever, M., Klicek, R., Blagaic, A., Tvrdei, A., Kralj, T., Kovac, K., Vukojevi, J., Siroglavi, M., Gojkovic, S., Krezic, I., Pavlov, K., Rasic, D., Mirkovic, I., Kokot, A., krti, A., & Seiwerth, S

Originally nominated for Category 2 (Bulk Substances that Raise Significant Safety Concerns), the withdrawal of these nominations would indicate that the FDA is reconsidering the validity of respective safety concerns

Key mechanistic observations from laboratory studies: G-actin sequestration: TB-500 binds monomeric G-actin, regulating the pool available for filament polymerization