{
  "schema_version": "1.1",
  "id": "M-001",
  "date": "2026-10-23",
  "status": "unreviewed_editorial_assumption_scenario_NOT_statistically_calibrated",
  "display_purpose": "Sensitivity analysis only; not a locked or official Cortist forecast probability",
  "probability_percent": 46,
  "scenario_sensitivity_range_percent": [
    20,
    72
  ],
  "range_interpretation": "Judgmental / illustrative parameter variation; NOT a statistical confidence or credible interval",
  "model_type": "conditional event-tree assumptions",
  "model_expression": "P(one eligible FDA approval by 2032) x P(verified AI molecular design | approval)",
  "assumptions": [
    {
      "label": "At least one genuinely eligible FDA authorization by 2032",
      "p": 0.65,
      "basis": "Judgmental assumption: company-reported rentosertib Phase III enrollment in September 2026 plus several less-mature AI-related pipelines; not a frequency derived from observed AI drug approvals."
    },
    {
      "label": "Public independent substantive AI design documentation, conditional",
      "p": 0.7,
      "basis": "Judgmental assumption; clinical approval is not itself proof of AI molecular design and Nature Reviews Drug Discovery finds attribution often opaque."
    }
  ],
  "sensitivity": [
    {
      "case": "conservative",
      "factors": [
        0.4,
        0.5
      ],
      "probability": 20
    },
    {
      "case": "working",
      "factors": [
        0.65,
        0.7
      ],
      "probability": 45.5
    },
    {
      "case": "optimistic",
      "factors": [
        0.85,
        0.85
      ],
      "probability": 72.25
    }
  ],
  "limitations": [
    "45% is a preliminary editorial judgment, NOT an FDA, clinical trial or independent scientific probability.",
    "Rentosertib being in Phase III does not mean US FDA authorization is likely or guaranteed.",
    "The documented de novo design standard is stricter than general AI-enabled drug discovery.",
    "Clinical events and publication of provenance may be correlated, so a simple product is only a heuristic."
  ],
  "sources": [
    {
      "title": "Insilico Medicine: Phase III enrollment September 2026 (company claim)",
      "url": "https://insilico.com/news"
    },
    {
      "title": "Nature Reviews Drug Discovery: attribution and limitations (2026)",
      "url": "https://www.nature.com/articles/s41573-026-01496-2"
    },
    {
      "title": "FDA official novel therapy approvals",
      "url": "https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026"
    },
    {
      "title": "Published early clinical success-rate analysis",
      "url": "https://pubmed.ncbi.nlm.nih.gov/38692505/"
    }
  ],
  "prelock_requirements": [
    "Specify what patents or other independent documents prove substantive de novo molecular design, with blinded independent reviewers.",
    "Freeze allowed new-drug and biologics classifications, geography (US FDA only), and approval deadline.",
    "Build an auditable pipeline-wide historical base rate including trial phase and selection bias, not only favorable company examples."
  ],
  "forecaster_signoff": false,
  "independent_review_count": 0,
  "locked": false,
  "scoring_eligible": false,
  "automatic_score": false,
  "source_candidate": "/data/forecasts/research/m-001.json",
  "candidate_page": "/forecast/ai-designed-drug-fda-approval-2032/",
  "version": "0.2",
  "audit_date": "2026-10-23",
  "pre_review_result": "HOLD_NOT_READY_FOR_INDEPENDENT_REVIEW_SIGNOFF",
  "precise_model_working_probability": 45.5,
  "rounding_rule": "nearest whole percentage point; exact .5 rounds upward",
  "previous_displayed_percentage": 45,
  "correction": "v0.1 displayed 85% and 45% for the exact 85.5% and 45.5% calculations; v0.2 corrects to 86% and 46% under the stated standard rounding rule. E-001 remains 54%.",
  "audit_record": "/data/forecasts/review/m-001-method-audit-20261023-v02.json",
  "previous_version": "/data/forecasts/calibration/m-001-working-20261023.json",
  "external_reviewer_signoffs": 0,
  "independent_validation_complete": false
}
