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Thats a case where the B12 component provided real, measurable benefit

Theyre wanting a certain amount of certitude that, frankly, is appropriate for most drugs, but not for this moment. Regulatory shortcuts exist that would allow the FDA to skip the more laborious approval process

Please note: The consumption of bread and cereals fortified with folic acid (synthetic folate) may mask a B12 deficiency on standard lab tests

Butler CC et al