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  "notes": "Explains the 505(b)(2) pathway and associated market exclusivity.",
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      "text": "A 505(b)(2) New Drug Application (NDA) provides 3 years of market exclusivity. Niclosamide NDA was withdrawn in 1996 due to low incidence of tapeworm in the U.S. Three-year exclusivity period would block the approval of any generic drugs.",
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      "text": "NRBO is pursuing an abbreviated regulatory pathway using A 505(b)(2) New Drug Application (NDA). This allows for referencing all the safety data from niclosamide's original approval.",
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      "text": "The three-year exclusivity period may be extended by 6 months with pediatric exclusivity.",
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      "text": "Continue to supplement the provisional filings, which include clinical data from COVID patients. Potential to strengthen IP in priority regions globally.",
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      "text": "Hatch-Waxman Exclusivity and Intellectual Property",
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