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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
Activation of ferroptosis would be helpful to enhance sensitivity of cancer cells to chemotherapeutic agents (Zheng and Guan, 2023)
Let both the peptide and the bacteriostatic water reach room temperature before mixing
Cani PD, Montoya ML, Neyrinck AM, Delzenne NM, Lambert DM
The Swiss-derived SHR study did not find a reduction in total spontaneous tumour incidence, although it reported a lower leukaemia frequency
Are generic alternatives available for either of these medications
