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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 a redacted document image to illustrate the lack of transparency in the FDA's review process compared to the EMA's.",
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      "text": "FDA review redacts the entirety of the purported pre-specified Statistical Analysis Plan",
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      "text": "The EMA review makes no mention of this purported pre-specified Statistical Analysis Plan and bluntly states it was “not pre-planned analysis.”",
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      "text": "Figure 14: Pre-Specified Plan for Clustering of Centers - HARMONY I-BIS",
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      "text": "The FDA blithely accepted Harmony’s explanation that the 1-bis Statistical Analysis Plan issued a month before database lock included an appendix to display the clustering, and took at face value that this plan was “amended prior to unblinding of the study.” The FDA then shows the Statistical Analysis Plan in a table, but it is entirely redacted - presumably at Harmony’s request. We are troubled that something so innocuous would be redacted - on top of the fact that the data was never published in a paper - and are curious what Harmony was so worried about. The EMA review makes no mention of this purported pre-specified Statistical Analysis Plan and bluntly states it was “not pre-planned analysis.” If this plan existed, it would have been provided to the EMA as well and the review would have noted it.",
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      "kind": "quote",
      "text": "“amended prior to unblinding of the study.” — Harmony Biosciences (as cited by Scorpion Capital)",
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      "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000MedR.pdf",
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      "text": "Source – Statistical Analysis Plan, HARMONY I-BIS, page 11",
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