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  "documentTitle": "See the pitch deck that Compass Pathways used to raise $80 million and fuel its rise into one of the world's biggest psychedelics companies",
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  "authorName": "Compass Pathways",
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  "notes": "The table provides a quantitative comparison of clinical trial characteristics for BTD vs non-BTD pathways, highlighting the efficiency gains.",
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      "kind": "callout",
      "text": "COMPASS received ‘Breakthrough Therapy’ designation (BTD) from US Food and Drug Administration (FDA) in Oct-2018 for its psilocybin therapy for treatment-resistant depression (TRD).",
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      "text": "‘Breakthrough Designation’ is awarded to investigative therapies with evidence demonstrating substantial improvement in serious or life-threatening condition\nMost are related to cancer (54%), followed by infectious disease (17%)\nIn psychiatry, few therapies have recently received BTD, eg Esketamine (2013, 2016), Sage-217 (2018)\nBTD is intended to accelerate approval of therapies and availability to patients",
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      "kind": "metric",
      "text": "IND-to-Approval timeline: 4.9 years",
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      "text": "COMPASS received ‘Breakthrough Therapy’ designation (BTD) from US Food and Drug Administration (FDA) in Oct-2018 for its psilocybin therapy for treatment-resistant depression (TRD). This is a significant milestone for psilocybin therapy and psilocybin research, and a testament to the work done over many years by research teams in the US, the UK, and Switzerland.",
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      "kind": "source-note",
      "text": "1. Fast Track award from FDA leads to more meetings and written communications with FDA for trial design and eligibility for Accelerated Approval award",
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      "text": "Clinical Programme Aspect | BTD | Non-BTD\nTrial Programme | No. Pivotal Trials | 1 | 2\nSubjects | Total No. Subjects | 222 | 446\nSubjects | Double Blinding | 46% | 80%\nSubjects | Randomisation | 59% | 89%\nComparators | Placebo/Active/Indirect | 65% | 87%\nComparators | None | 35% | 13%\nTimelines | IND-to-Approval | 4.9 years | 12 years\nTimelines | Submission-to-Approval | 7 months | 2 years\nFast Track | Likelihood of Award | 39% | 12%",
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      "kind": "title",
      "text": "FDA ‘Breakthrough Therapy’ Designation: Award for psilocybin in TRD in October 2018 could mean faster access to patients",
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