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Phase 5: Commercial Launch (Year 8 onward, subject to exclusivity) Final approval cannot become effective before reference product exclusivity expires (12 years from first licensure, plus any pediatric extension)

Having a sufficient amount of B12 in our bodies will improve overall cognitive functioning, as well as ensure that our bodies have enough energy to get through the day

3 The imbalance in NAD+/NADH ratios can lead to impaired cellular stress responses and metabolic dysfunctions, which are characteristic of metabolic diseases

The oxidation of lactate by LDH-B increases the intracellular pool of pyruvate that competes with 2-oxoglutarate and inhibits the hydroxylase activity of PHD

This can result in temporary sensory and perceptual disturbances as well as permanent structural damage to the nervous system