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These symptoms arise due to the damage that a lack of B12 can inflict on the nervous system

The only approvability issue is related to the enrollment status of the confirmatory trials, according to Regenerons announcement

Thymosin beta-4 (the molecule behind TB-500) is best supported for central neurorestoration and remyelination : driving oligodendrocyte-progenitor differentiation and remyelination, stimulating neurogenesis and angiogenesis in injured cortex and hippocampus, and promoting neurite outgrowth in models where lesion size does not change but function still improves

PHYSIOLOGICAL CONSEQUENCES Manipulating GH, IGF 1, inflammatory signalling, or mitochondrial pathways is not benign