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      "text": "The biometrics review provides a chronology of how the FDA reviewer yet again gave Bioprojet a pass despite obvious red flags and accepted HARMONY 1 as a second trial in support of cataplexy along with CTP.",
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      "text": "The Applicant requested a Type A Post-Action face to face meeting, for reconsideration of the CRL decision, and the meeting was held on December 12, 2019 to discuss the Applicant's re-analysis of the clinical data...",
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      "text": "FDA biometrics review (excerpt) provides chronology for how HARMONY 1 went from CRP to being accepted as the second trial in support of the cataplexy indication",
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      "text": "“highlighted with apology this inconsistency [that] arose due to statistician error,” — Bioprojet. “vehemently agreed with the agency about the need to prespecify primary and secondary endpoints.” — Bioprojet. “sponsor acknowledged the errors and rectified the efficacy tables...this did not change the overall conclusion but took arduous effort from the statistical reviewer to make sure the sponsor presented accurate analysis results.” — FDA Reviewer.",
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