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The slide highlights the safety margin between the recommended dose (40mg) and the doses where QTc prolongation was observed (120-240mg), while noting specific patient populations at higher risk.Harmony Biosciences (HRMY) · Scorpion Capital
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135
The slide uses a 'before-after' logic to expose a flaw in regulatory reliance on single-dose data. The red box highlights the critical 'Upper limit TQT' values in the corrected table.Harmony Biosciences (HRMY) · Scorpion Capital
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148
The slide uses a combination of narrative argument and a supporting data table to challenge the safety profile of the drug.Harmony Biosciences (HRMY) · Scorpion Capital
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174
The slide argues that reporting lags or manipulation by Harmony Biosciences obscures the true number of adverse events.Harmony Biosciences (HRMY) · Scorpion Capital
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175
The slide uses a list of adverse events to build a case for cardiotoxicity, highlighting specific fatal and serious outcomes.Harmony Biosciences (HRMY) · Scorpion Capital
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178
The slide highlights a potential discrepancy between official FDA reporting and actual event timing, suggesting either database lag or manufacturer reporting delays.Harmony Biosciences (HRMY) · Scorpion Capital
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179
The slide uses a 'back-of-the-envelope' calculation to argue that reported adverse events are undercounted.Harmony Biosciences (HRMY) · Scorpion Capital
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211
The slide uses a table from a Lancet paper to argue that pitolisant's performance was inferior to modafinil, contradicting the company's narrative.Harmony Biosciences (HRMY) · Scorpion Capital
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212
The slide uses a pie chart to highlight that 38% of study participants were in Russia, suggesting a lack of geographic diversity and potential data manipulation.Harmony Biosciences (HRMY) · Scorpion Capital
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220
The slide uses a critical tone to re-evaluate clinical trial data, highlighting the gap between statistical results and clinical meaningfulness.Harmony Biosciences (HRMY) · Scorpion Capital
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221
The slide uses clinical trial data to undermine the efficacy claims of a drug by highlighting the placebo response.Harmony Biosciences (HRMY) · Scorpion Capital
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222
The slide uses FDA biometrics review data to challenge the efficacy timeline of the drug Wakix (pitolisant).Harmony Biosciences (HRMY) · Scorpion Capital
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223
The author argues that the discrepancy hides a trend reversal that would undermine the trial's efficacy claims.Harmony Biosciences (HRMY) · Scorpion Capital
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227
The slide highlights a discrepancy between the reported trial results and the underlying patient-level data regarding dosage and efficacy.Harmony Biosciences (HRMY) · Scorpion Capital
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229
The slide highlights a specific regulatory failure/contradiction regarding the acceptance of post-hoc analysis in clinical trials.Harmony Biosciences (HRMY) · Scorpion Capital
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232
The slide highlights a discrepancy between raw ESS scores and adjusted LS means, accusing the sponsor of data manipulation.Harmony Biosciences (HRMY) · Scorpion Capital
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236
The slide uses a pie chart to visualize the geographic concentration of trial participants, specifically pointing out the high percentage in Russia to support a claim of data manipulation.Harmony Biosciences (HRMY) · Scorpion Capital
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242
The slide uses a CONSORT-style flow diagram to illustrate patient attrition in a clinical trial.Harmony Biosciences (HRMY) · Scorpion Capital
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243
The slide uses red boxes and text annotations to highlight specific data points (M6 for ESS, M12 for cataplexy) that contradict expected outcomes.Harmony Biosciences (HRMY) · Scorpion Capital
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244
The slide uses a comparative analysis of clinical trial data to challenge the validity of the HARMONY 3 results.Harmony Biosciences (HRMY) · Scorpion Capital
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245
The slide uses red text and boxes to emphasize the contradiction between the trial paper's claims and the EMA's findings.Harmony Biosciences (HRMY) · Scorpion Capital
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256
The slide uses direct quotes from a physician to highlight low adoption and skepticism.Harmony Biosciences (HRMY) · Scorpion Capital
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270
Includes verbatim Q&A excerpts highlighting patient volume and discontinuation rates.Harmony Biosciences (HRMY) · Scorpion Capital
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274
The slide presents qualitative expert testimony regarding drug discontinuation rates.Harmony Biosciences (HRMY) · Scorpion Capital
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281
The slide presents a transcript of an interview with a physician, highlighting negative clinical experience.Harmony Biosciences (HRMY) · Scorpion Capital
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307
The slide uses a combination of narrative argument and direct excerpts from regulatory documents to highlight a discrepancy in drug efficacy claims.Harmony Biosciences (HRMY) · Scorpion Capital
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308
The slide uses a strong accusatory tone, alleging fraudulent claims and intent to mislead the FDA.Harmony Biosciences (HRMY) · Scorpion Capital
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310
The slide uses a specific scientific paper (Lin et al., 2007) to argue that the drug's mechanism is scientifically implausible based on the provided data.Harmony Biosciences (HRMY) · Scorpion Capital
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313
Includes a quote from a pharmacology consultant comparing pitolisant to antihistamines.Harmony Biosciences (HRMY) · Scorpion Capital
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314
The slide uses red boxes and text annotations to highlight specific data points in the charts that contradict expected clinical outcomes.Harmony Biosciences (HRMY) · Scorpion Capital
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