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      "kind": "callout",
      "text": "EMA review (Annex 1) indicated massive discontinuation rates,",
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      "text": "The paper states that 90% of the patients who discontinued did so within 3 months, so the 12-month discontinuation rate of 30-50% is a 90-day figure in disguise.",
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      "text": "The trial followed patients for 5 years, even though the trial paper (2019) fails to disclose this fact, and nor does it show any data beyond the first year. However, an appendix buried in the EMA review for pitolisant circa 2015 contained a nugget - of 102 patients, 68 (67%) were left at 12 months, and only 44%, 37%, 33%, and 14% at years 2, 3, 4, and 5. The paper states that 90% of the patients who discontinued did so within 3 months, so the 12-month discontinuation rate of 30-50% is a 90-day figure in disguise.",
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      "text": "If the 12-month discontinuation rate is 30-50%, what is it in years 2 and 3? For investors seeking a clue into Harmony’s predicament, we note HARMONY 3, a one-year foreign open-label trial, which we analyze in a later chapter.",
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      "text": "The maximal dose received during the study was 36 mg / day in 85% of patients. After 12 months of treatment, improvements in EDS assessed by ESS score of remaining patients is of same magnitude as those observed in the other trials conducted in narcoleptic patients. The decrease in mean ESS score (SD) was -3.62 (4.63) after 1 year.",
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      "text": "The open-label, long-term Phase III study (HARMONY III) assessed the long term safety of pitolisant in patients suffering from narcolepsy (with or without cataplexy) over 12 months and with an extension of up to 5 years. 102 narcoleptic patients with or without cataplexy were included in the 12 months follow-up period. 68 patients completed the first 12 months period. 45, 38, 34 and 14 patients completed the 2, 3, 4 and 5 year follow-up periods, respectively.",
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      "text": "EMA review (Annex 1) indicated massive discontinuation rates. — EMA review",
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