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Both FDA investigators and industry experts emphasize that it is not the 483 but the response that triggers the warning letter

Moreover, MSH3 deficiency demonstrates comprehensive therapeutic potential by correcting synaptic dysfunction, astrocytic abnormalities and locomotor deficits in HD mice ( MSH3 and PMS1 play pivotal roles in driving accelerated somatic mHTT CAG expansion rates specifically in HD-vulnerable neurons, underlying the repeat length-dependent, threshold-sensitive, selective and progressive pathogenesis in vivo