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All current research is in animal models no completed human clinical trials exist so it remains strictly a research compound at this stage

Autoimmune and Neuropathy: Chemotherapy-induced neuropathy: B12 supplementation may also be beneficial for patients with autoimmune conditions that cause nerve damage

Safety and Tolerability Based on available research and clinical use patterns: Cartalax is well tolerated It is non-hormonal It does not suppress immune function It does not stimulate abnormal tissue growth Its tissue specificity contributes to its favorable safety profile

FDA Review Timeline FDA goal: ~150 days Total timeline: 612 months Typical Process Common Delays De Novo requires more data than 510(k), but less than PMA