{
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  "docSlug": "ce565b841c40",
  "documentTitle": "Nevro Corp. (NVRO)",
  "authorId": "58_Scorpion_Capital",
  "authorName": "Kir Kahlon",
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  "sourceTypeLabel": "Short seller",
  "presentationDate": "2021-01-07 00:00:00",
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  "pageNumber": 58,
  "pageCount": 239,
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  "slideType": "expose_contradiction",
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  "notes": "Uses excerpts from a press release and a clinical paper to highlight study design flaws.",
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      "kind": "callout",
      "text": "As with any clinical trial, there are limitations. Study investigators and subjects were not masked to the assigned treatment group. Subject masking was impractical because low-frequency SCS produces paresthesias, whereas high-frequency SCS does not; thus, the therapies themselves become immediately known to the subjects. Due to the differences in stimulator lead placement, intraoperative testing, and device programming between the treatment groups, the study investigators could not be masked. The effect of the lack of masking in this randomized study is not known; nonetheless, the protocol was based on best practices guidance for comparative efficacy trial designs.",
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      "kind": "other",
      "text": "Source: https://news.bostonscientific.com/news-releases?item=58980; SENZA-RCT paper https://s24.q4cdn.com/932612397/files/doc_downloads/Comparison_of_10_kHz_High_Frequency_and.97253.pdf",
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      "kind": "paragraph",
      "text": "Red flags in the study design are apparent at the outset, as one might expect in a sham exercise designed to enable an IPO and FDA approval. The study compared Nevro’s new high frequency device against the Boston Scientific Precision Plus - a legacy, low frequency stimulator system launched many years prior in 2007. Notably, the study wasn’t blinded: patients knew whether they were the unlucky ones being implanted with an ancient stimulator or the fortunate few receiving the latest breakthrough.",
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      "kind": "paragraph",
      "text": "SENZA-RCT paper describing comparator arm and study limitations due to lack of patient and investigator blinding",
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      "kind": "paragraph",
      "text": "Boston Scientific July 2, 2007 press release",
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      "kind": "paragraph",
      "text": "Boston Scientific Announces Launch of New Precision Plus™ Spinal Cord Stimulation System",
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      "text": "Subjects were randomized 1:1 to receive stimulation with either an HF10 therapy system (Senza system; Nevro Corp., Redwood City, California) or a commercially available SCS system (Precision Plus system; Boston Scientific, Natick, Massachusetts). Both SCS systems consisted of two 8-contact leads.",
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      "kind": "title",
      "text": "3. Trial investigators, KOL's, and ex-employees painted the SENZA pivotal study as a fraud",
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      "kind": "title",
      "text": "Scorpion Capital | Nevro (NYSE: NVRO)",
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      "evidence": "The slide explicitly frames the clinical trial as a 'sham exercise' and 'fraud' to expose potential corporate misconduct.",
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      "arcName": "Overcoming the Monster",
      "arcSlug": "overcoming-monster",
      "beatName": "The Victory",
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      "evidence": "The deck presents a conclusion that Nevro's problems are insurmountable",
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      "name": "Cost Of Inaction",
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      "evidence": "The deck emphasizes the risks of not addressing Nevro's problems",
      "position": 1,
      "objective": "Highlight the cost of inaction",
      "structure": "The Status Quo -> The Hidden Costs Accumulating -> The Future State of Inaction -> The Tipping Point",
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      "description": "Quantify what happens if the audience does nothing"
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