{ "docId": "019dd923-622c-750b-8b9a-21918ac10c17", "docSlug": "f3db2294dcf9", "documentTitle": "Harmony Biosciences (HRMY)", "authorId": "58_Scorpion_Capital", "authorName": "Scorpion Capital", "documentKindSlug": "research-note", "documentKindLabel": "Research note", "sourceTypeSlug": "short_seller", "sourceTypeLabel": "Short seller", "presentationDate": "2023-03-28 00:00:00", "orientation": "landscape", "aspectRatio": 1.3333334, "pageNumber": 41, "pageCount": 366, "prevPage": 40, "nextPage": 42, "slideType": "expose_contradiction", "function": "expose_contradiction", "density": "dense", "nDataPoints": 2, "notes": "The slide uses a Q&A format to highlight potential corporate malfeasance regarding clinical trial adverse events.", "elementsJson": [ "paragraph", "quote_block" ], "metadataConfidence": 1, "imagePath": null, "slideHref": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/41", "deckHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckJsonHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json", "deckAnchorHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-41", "components": [ { "bbox": null, "kind": "callout", "text": "To protect the welfare of the patients, it was decided to stop the study....but because the marketing authorization was in danger.", "attrs": null, "subkind": null, "toolName": "Visual emphasis", "toolSlug": "visual-emphasis", "confidence": null, "componentId": "019dd953-64d0-7099-9ccc-173346e56a9f", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.03, "w": 0.6, "x": 0.07, "y": 0.43 }, "kind": "list", "text": "Ex-employee listed the trial sites which had issues, and stated the EMA approval was in danger", "attrs": null, "subkind": "bullet", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "a7abba17-f0f1-4133-b311-2a75c2e1858d", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.47 }, "kind": "paragraph", "text": "Q: “Do you remember the names of the sites who the doctors were that observed the liver problem—which sites?”\nA: “Yes, it was Dr. [redacted].”\nQ: “So, he observed some liver side effects?”\nA: “Exactly, yes. And the other was—the site where the problem was observed was [redacted] with Dr. [redacted]”\nQ: “And what did she say about the drug?”\nA: “She decided to review the calibration of the machine to be sure that the bad blood result observed was due to the product. She asked for a plan and the upper management of Bioprojet decided to stop the study.”\nQ: “What was her reaction?”\nA: “You know it was a difficult moment because we were trying to get the marketing authorization. The upper management of Bioprojet was worried about that. To protect the welfare of the patients, it was decided to stop the study. But because the marketing authorization was in danger.”\nQ: “And what do the doctors say when they brought it up? They said I have these blood results - they don't look good?”\nA: “The bad result was declared as an adverse event. At first, they decided to review the calibration of the machine to be sure the problem did not occur from the machine. But when it had been confirmed that, in fact, the bad blood result was observed - it was to report it, they asked us, Bioprojet for a plan but Bioprojet, they decided to stop the study.”\nQ: “So, what did the doctors say? They said the patient is having blood problems - I'm worried?”\nA: “Yes, they sent an alert about the problem. They said we observed a bad blood result. What is your decision?” – Former Bioprojet employee", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "0af958a2-a301-4c1f-9cc0-87ca1f53773d", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The ex-employee stated that 8 patients out of 102 on pitolisant exhibited the issue. He was not able to recall which enzyme or details of the labwork, given the trial was conducted 2011-2016 per ClinicalTrials.gov. The expert was a French speaker whose English was mediocre, but we view the information as credible as his color regarding which trial sites and investigators reported the adverse event was specific, as were his recollections of meetings with Bioprojet management. He stated the investigators checked the calibration of their lab equipment to verify the finding, and then pressed Bioprojet for a plan and a decision – “it was a difficult moment because we were trying to get the [EMA] marketing authorization...upper management was worried about that...to protect the welfare of the patients, it was decided to stop the study....but because the marketing authorization was in danger.”", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "542875a3-97bf-4b1d-a151-34740abd3854", "frameworkName": null, "frameworkSlug": null }, { "bbox": null, "kind": "quote", "text": "“You know it was a difficult moment because we were trying to get the marketing authorization. The upper management of Bioprojet was worried about that. To protect the welfare of the patients, it was decided to stop the study. But because the marketing authorization was in danger.” — Former Bioprojet employee", "attrs": null, "subkind": null, "toolName": "Authority citation", "toolSlug": "authority-citation", "confidence": null, "componentId": "019dd953-64d0-7099-9ccc-188d74f09187", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.02, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "subkind": null, "toolName": null, "toolSlug": null, "confidence": null, "componentId": "e05ccc59-5048-4804-a485-ce04f93f1621", "frameworkName": null, "frameworkSlug": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [ { "to": 50, "from": 31, "beatId": "2b789ae4-940c-4d3a-9f03-7f2e7e4f46fd", "arcName": "Overcoming the Monster", "arcSlug": "overcoming-monster", "beatName": "The Struggle", "beatSlug": null, "evidence": "The document presents the struggle of the company's critics and short-sellers to expose the truth", "position": 2, "confidence": 0.8, "parentBeatName": null, "parentBeatSlug": null } ], "loops": [], "imagePathAlt": null, "thumbSrc": null, "thumbSrcAlt": null, "locked": true }