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  "notes": "The slide uses a process diagram to illustrate the clinical trial design and highlights the lack of transparency in the dose-escalation phase.",
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      "text": "We are concerned by the lack of disclosure around the ongoing Phase 1 study. This is an open-label study, and the lack of updates and missing initial guidance is not a good sign.",
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      "text": "In November 2020, PMV Pharma initiated a Phase I dose-escalation study of PC14586 in patients with advanced solid tumors and Y220C mutated p53. The goal of this portion of the Phase 1/2 trial is to identify a maximum tolerated dose (MTD) and recommended dose to move into the Phase 2 (RP2D) expansion studies in select target indications. And yet, the company has provided minimal updates on the dose-escalation study over the past 17 months.",
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      "text": "We are concerned by the lack of disclosure around the ongoing Phase 1 study. This is an open-label study, and the lack of updates and missing initial guidance is not a good sign. Moreover, and this should matter to the SEC, although management is not talking publicly about the data, they are apparently sharing information with select sell-side analysts:",
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      "text": "In April 2021, at the American Association for Cancer Research (AACR) annual meeting, PMV Pharma’s SVP of Preclinical Development and Translational Science, Melissa Dumble, PhD, presented the research around PC14586 and the current Phase 1/2 study in a short video. During the video, Dr. Dumble noted initial data were expected soon, “By the end of the year or early next year.” More information can be found in an abstract published in the AACR journal in July 2021.",
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      "text": "By the end of the year or early next year. — Dr. Melissa Dumble, SVP of Preclinical Development and Translational Science",
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      "kind": "title",
      "text": "The Results of PMV’s Phase I Dose Escalation Study Have Been Delayed, But Select Non-Public Data Shared with Sell-Side Analysts Indicate That the Drug Lacks Potency in Humans",
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