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  "documentTitle": "Vivani Medical | Mergers and Acquisitions Presentation Deck | 27 slides",
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  "notes": "The slide uses a timeline-like structure to show both the commercial validation (deal size/valuation) and the regulatory hurdles (CRL) faced by the analog product.",
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      "text": "Value of long-term GLP-1 (exenatide) implant externally validated previously",
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      "text": "2014 - Intarcia signed ITCA 650 deal with Servier ($171M up-front, $880M milestones, double-digit royalties)\nFinancings valued Intarcia as high as $4.0B (2017)\nIntarcia's lead program was ITCA 650",
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      "text": "2016 - Intarcia filed initial ITCA 650 New Drug Application (NDA)\n2017 - FDA issued the first ITCA 650 CRL* (cited manufacturing concerns)\n2019 - Intarcia re-submitted ITCA 650 NDA\n2020 - FDA issued second ITCA 650 CRL (cited clinical safety and device constituent concerns)\n2022 - After multiple dispute resolution actions, FDA denied Intarcia's request for public hearing",
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      "text": "* CRL: Complete Response Letter – issued by FDA to identify NDA deficiencies",
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      "kind": "title",
      "text": "Intarcia's ITCA 650 (6-month exenatide implant) may be a relevant value analog for NPM-119",
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