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  "documentTitle": "Nevro Corp. (NVRO)",
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  "authorName": "Kir Kahlon",
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  "notes": "The slide uses direct quotes from KOLs and former executives to undermine the credibility of Nevro's clinical trials.",
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      "text": "One KOL called it \"the dumbest study design\" and \"greaseball,\" lamenting why Nevro doesn't \"just come out with a normal study?\"",
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      "text": "The former executive described patient manipulation and \"interaction bias\" as typical Nevro conduct curing trials",
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      "text": "A former executive as well a KOL strongly criticized the use of CMM as a comparator arm",
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      "text": "KOL's – as well as Nevro's former executives – expressed disdain at other flaws in the PDN study beyond cherry-picked patients. One KOL called it \"the dumbest study design\" and \"greaseball,\" lamenting why Nevro doesn't \"just come out with a normal study?\" The concerns include the use of CMM (\"Conservative Medical Management\") as a low-bar comparator arm that ensures \"a layup\" study; interaction bias and patient manipulation during the trial; and placebo effect from lack of blinding.",
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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 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.\" – Former Nevro executive",
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      "text": "\"One thing that concerns me is the huge amount of Nevro's valuation associated with PDN. It seem like half the valuation is linked to their PDN study. That study shows amazing results, but if you look at their control it's always CMM [conservative medical management] so these studies are always a layup.\" – Former Nevro executive",
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      "text": "\"And then the study also doesn't compare a Lamborghini to a Ferrari. They compared a stimulator to not another stimulator, but against just medication management. It is the dumbest study design. It's greaseball. And as doctors we just shake our heads and say, \"Why doesn't Nevro just come out with a normal study?\" – KOL and speaker",
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      "text": "\"One thing that concerns me is the huge amount of Nevro's valuation associated with PDN. It seem like half the valuation is linked to their PDN study. That study shows amazing results, but if you look at their control it's always CMM [conservative medical management] so these studies are always a layup.\" — Former Nevro executive; \"And then the study also doesn't compare a Lamborghini to a Ferrari. They compared a stimulator to not another stimulator, but against just medication management. It is the dumbest study design. It's greaseball. And as doctors we just shake our heads and say, \"Why doesn't Nevro just come out with a normal study?\" — KOL and speaker; \"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 Nevro executive",
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      "text": "Source: Consultation calls with experts",
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      "text": "11. TAM expansion and growth from painful diabetic neuropathy (PDN) and other new indications are a mirage",
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      "text": "Scorpion Capital | Nevro (NYSE: NVRO)",
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