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FDA approval requires a New Drug Application (NDA) with clinical trial data submitted for review

Cetinje, Montenegro, pp 19 Habig WH, Pabst MJ, Jakoby WB (1974) Glutathione S -transferases

Progressive accumulation of amyloid beta (A) extracellularly and accumulation of mutant hyperphosphorylated tau protein intracellularly, which results in neurofibrillary tangles (NFTs), are the causes of AD neuropathology