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In its SMAD pathway, TGF- binds to type II receptors, leading to the phosphorylation of downstream R-SMADs (R-SMAD2 and R-SMAD3) (Jones et al., 2009)

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Unregulated Production: Without FDA approval, there's no regulatory oversight on the manufacturing of TB-500

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Yet the number of completed, published Phase III human trials remains zero

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