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Genetically, ASD can be linked to identifiable genetic syndromes, such as Fragile X, Tuberous Sclerosis, Neurofibromatosis I, ADNP syndrome, and copy number variations (Lubbers et al., 2024
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2 For a 505(b)(2) sponsor, these new indications represent a value continuum where they can repurpose an established molecule for a specialized population with much lower risk
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