STAT3 and neoplasm: Even formulations with robust antitumor efficacy in murine models, such as Gan Sui Bian Xia Tang (GSBXD), which reduced myeloid-derived suppressor cell (MDSC) accumulation and modulated CD3+NK1.1+ NK-cell ratios via inhibition of the AKT/STAT3/ERK pathway in H22 tumor-bearing mice (123), lack the GLP-compliant toxicology, dose-ranging, and immunotoxicity profiles required to support an Investigational New Drug (IND) application.