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      "text": "LAYER 1: REGULATORY EXCLUSIVITY\nFDA: 5 years (+2.5 years paragraph IV stay)\nEMA: 10 years (+1 year for new indication)\n\nLAYER 2: PATENTS\nPatent families filed relating to mebufotenin (5-MeO-DMT), including:\n• Novel uses in various disorders (including inhaled, nasal, buccal, sublingual, i.v., i.m., s.c. routes)\n• Novel aerosol compositions of matter\n• Novel manufacturing methods and novel salt forms\n• Novel device-related aspects\n\nLAYER 3: TECHNICAL\nComplex bioequivalence for systemically-acting inhalation/intranasal products with high intra- and inter-subject variability",
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