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  "documentTitle": "Prothena Corp PLC (PRTA)",
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      "text": "if nothing else, this shows how a Best Response Analysis overstates the results of the trial.",
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      "text": "There have been no control arms. Based on what we understand of the trial, it seems one patient could be counted as a responder multiple times.",
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      "text": "Also, if we look at the six patients who each had at least six cycles of therapy, we see that while five out of six each had a response at some point in time (a Best Response Rate of 83%), at most points in time the response rate was 50% - if nothing else, this shows how a Best Response Analysis overstates the results of the trial.",
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      "text": "We repeatedly state throughout this report that seeing data on an individual patient level would go a long way to allowing investors to sort out whether improvements in biomarker levels were",
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      "text": "The Street seems to expect NEOD001's peak annual sales will approximate $1.5 billion or more. We see these estimates as extremely optimistic because AL amyloidosis is a rare disease, with approximately 4,500 new cases diagnosed in the U.S. per year.",
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      "text": "It appears PRTA has not published any dose-specific data since 2014, nor does it appear to have published dose-specific data on doses between 8.0 mg / kg and the Phase 3 dose of 24 mg / kg.",
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      "text": "Gertz et al. J Clin Oncol 34:1097-1103, 2016 — Footnote 17",
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      "text": "Cycle 2: 50%, Cycle 3: 50%, Cycle 4: 50%, Cycle 5: 83%, Cycle 6: 33%",
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      "text": "Even if the FDA Approves NEOD001, it is Unclear to us how it will Achieve Analysts' Expectations for Peak Annual Sales",
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      "text": "Insiders Have Near Zero Share Ownership",
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      "text": "Other Criticisms About Concluding NEOD001 is Efficacious from the Trial Data",
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