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  "documentTitle": "Sarissa Capital | Activist Presentation Deck | 95 slides",
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  "authorName": "Sarissa Capital",
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  "presentationDate": "2023-06-01 00:00:00",
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  "notes": "Uses a two-column layout to present evidence of operational failure.",
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      "text": "Alkermes Receives FDA Complete Response Letter Related to ALKS 3831 Manufacturing Records Review -- No Clinical Efficacy or Safety Issues Raised and No Further Studies Required by FDA to Support Approval -- Company Plans to Engage With FDA Toward Expeditious Resolution of Outstanding Items --",
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      "kind": "list",
      "text": "10-Q (3Q22): \"The decrease in manufacturing revenue in the three months ended September 30, 2022, as compared to the three months ended September 30, 2021, was primarily due to the manufacture of fewer commercial batches...\"",
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      "text": "Lybalvi received a complete response letter from FDA in 11/2020 due to manufacturing concerns. When Lybalvi was finally approved in 6/2021, launch was delayed until 10/2021 due to commercial manufacturing not being ready.",
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      "kind": "source-note",
      "text": "Source: Alkermes corporate filings and press releases",
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      "kind": "title",
      "text": "Manufacturing is not a core competency for Alkermes as recent missteps have shown",
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