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  "documentTitle": "Harmony Biosciences (HRMY)",
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  "authorName": "Scorpion Capital",
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  "presentationDate": "2023-03-28 00:00:00",
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  "notes": "The slide uses excerpts from French regulatory documents to prove the existence and negative results of the unpublished HARMONY 4 trial.",
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      "text": "HARMONY 4 info from a 2018 review paper; the paper cites unpublished data provided to the French National Authority for Health, which we located and excerpt below right (from French via Google translate)",
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      "text": "The trial showed no difference between the pitolisant group and placebo in ESS, nor secondary endpoints like reduction in cataplexy, quality of life, or maintenance of wakefulness test (MWT).",
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      "text": "Excerpts from French regulatory documents regarding the P10-01 (Harmony IV) study.",
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      "text": "The FDA's failure to incorporate either trial into its review was a grave error, as they were the most relevant, real-world trials conducted. Unlike the monotherapy pivotal trials upon which approval was based, these two trials evaluated pitolisant as an add-on to either modafinil or sodium oxybate, the two most common first line treatments. Our interviews with 20 physicians indicate that those willing to use pitolisant rarely do so as a standalone or first-line option and more typically as the third or fourth addition to a cocktail including modafinil and/or sodium oxybate. Former sales reps indicate the company's entire strategy is to market pitolisant as a combo therapy, given questions about its efficacy. Harmony 4 was conducted between Sep 2012 and Aug 2014, with 51 patients and the same primary endpoint as Harmony 1 – reduction in excessive daytime sleepiness (EDS) using the Epworth Sleepiness Scale (ESS). The trial showed no difference between the pitolisant group and placebo in ESS, nor secondary endpoints like reduction in cataplexy, quality of life, or maintenance of wakefulness test (MWT).",
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      "text": "No difference in terms of daytime sleepiness assessed by the Epworth scale (primary endpoint) was demonstrated between the two groups: at the end of the study the mean score had decreased by 2.6 points in the pitolisant group and 2.1 points in the placebo group (p=0.595). — French National Authority for Health (via Google translate)",
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      "text": "Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6124464/; https://www.has-sante.fr/upload/evamed/CT-14970_WAKIX_PIC_INS_Avis3_CT14970.pdf; https://clinicaltrials.gov/ct2/history/NCT01789398?A=1&B=9&C=merged#StudyPageTop",
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      "text": "HARMONY 4 was a debacle similar to HARMONY 2, and also never published.",
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