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  "documentTitle": "Nevro Corp. (NVRO)",
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  "authorName": "Kir Kahlon",
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  "presentationDate": "2021-01-07 00:00:00",
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  "notes": "The slide uses testimonials from former executives to build a case of fraud against the company's clinical trial methodology.",
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      "text": "In addition to cherry-picking and bias from lack of blinding, some of the most troubling allegations about the conduct of the trial came from former executives of Nevro, who described Nevro’s approach to studies at “highly unethical” and suggested Nevro’s skill at manipulating study patients.",
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      "text": "In addition to cherry-picking and bias from lack of blinding, some of the most troubling allegations about the conduct of the trial came from former executives of Nevro, who described Nevro's approach to studies at “highly unethical” and suggested Nevro's skill at manipulating study patients. The most damning comments below are by a former executive who we believe to maintain relationships with the CEO and management team, who suggested that Nevro suppresses data which contradicts their high frequency trial.",
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      "text": "The RCT patients were so closely followed up, so closely managed and optimized with full time field clinical engineers dedicated to them, that then going to a general population and not having that same support infrastructure, yeah, of course you're going to see some fall off [in efficacy versus the pivotal trial].",
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      "text": "What assisted Nevro with the Kapural study was interaction bias. It’s all about how the study was designed and how the study team interacted with patients in the Boston Scientific arm versus the Nevro arm. The Boston patients' stimulators were re-programmed the same as always. But the Nevro arm had a team come in. The patient knows it’s a new stimulator. The study team is excited to see you. You have 5 to 6 people at your programming session. They were methodical with patients in between sessions as well. Patients were managed differently. Nevro's PDN study would have managed patients exactly the same way, I'm sure. They compared Nevro to CMM [conservative medical management], and CMM is a very low bar.",
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      "text": "I have concerns and issues with how Nevro manages data especially around clinical research. If a study didn't produce results congruent with their high frequency trial, they wouldn't publish it. I feel that's highly unethical. They'd pay the study out and close it. I had a huge problem with that.",
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      "text": "Another factor is how Nevro managed patients post-implant is create their own placebo effect. Nevro has a management system that sees when to call a patient, what questions to ask. Pain patients have psychological comorbidities. It creates a crutch. Nevro is commercially savvy in the interaction cycle with the patient. My concern is that they do this during clinical trials.",
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      "text": "“What assisted Nevro with the Kapural study was interaction bias. It’s all about how the study was designed and how the study team interacted with patients in the Boston Scientific arm versus the Nevro arm... They compared Nevro to CMM [conservative medical management], and CMM is a very low bar.” — Former executive; “I have concerns and issues with how Nevro manages data especially around clinical research. If a study didn’t produce results congruent with their high frequency trial, they wouldn’t publish it. I feel that’s highly unethical.” — Former executive; “Another factor is how Nevro managed patients post-implant is create their own placebo effect... My concern is that they do this during clinical trials.” — Former executive; “The RCT patients were so closely followed up, so closely managed and optimized with full time field clinical engineers dedicated to them, that then going to a general population and not having that same support infrastructure, yeah, of course you’re going to see some fall off [in efficacy versus the pivotal trial].” — Former Nevro executive",
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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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      "text": "Scorpion Capital | Nevro (NYSE: NVRO)",
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