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Vitamin B 12 deficiency symptoms may include: strange sensations, numbness, or tingling in the hands, legs, or feet difficulty walking (staggering, balance problems) anemia a swollen, inflamed tongue difficulty thinking and reasoning (cognitive difficulties), or memory loss weakness fatigue While an experienced physician may notice the symptoms and be able to detect a vitamin B 12 deficiency with a good interview and physical exam, a blood test is needed to confirm the condition

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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

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