{
  "schema_version": "1.0",
  "version": "0.2",
  "created_at": "2026-10-23",
  "forecast_id": "M-001",
  "assessment_type": "internal_editorial_pre_review_NOT_independent",
  "external_reviewers_appointed": 0,
  "external_signoffs": 0,
  "threshold_for_independent_approval": 2,
  "result": "HOLD",
  "official_probability": null,
  "previous_working_model_display_percent": 45,
  "corrected_working_model_display_percent": 46,
  "correction_explanation": "0.65 x 0.70 = 0.455 = 45.5%; standard whole-percent rounding -> 46%",
  "sensitivity_percent": [
    20,
    72
  ],
  "sensitivity_is_statistical_confidence_interval": false,
  "independent_calibration_validated": false,
  "review_verdict": "The FDA approval outcome can be verified, but no independent public base rate supports the 65% authorization input or 70% AI-design provenance input. Phase III entry cannot substitute for phase-adjusted historical rates.",
  "verified_source_scope": [
    "The FDA publishes dated US novel therapy approval records, which do not establish whether AI originated the molecular design.",
    "Insilico reported first dosing in a Phase III trial of rentosertib in September 2026; this is a company report, not an FDA approval.",
    "An August 2026 Nature Reviews Drug Discovery perspective documents how opaque lead optimization frustrates reliable AI design attribution."
  ],
  "blocking_findings": [
    {
      "code": "DRUG-DESIGN",
      "severity": "critical",
      "task": "Predefine substantive de novo AI design of the actual approved molecule; require patents, dated experiment trails and independent audit, not marketing phrases."
    },
    {
      "code": "DRUG-REFCLASS",
      "severity": "critical",
      "task": "Estimate eligible pipeline base rates by trial phase and disease from independently verified approval histories; address censoring and selection bias."
    },
    {
      "code": "DRUG-FDA",
      "severity": "high",
      "task": "Define CDER vs CBER, NDA/BLA, accelerated approval and 2032 cutoff; resolve FDA authorization only from official records."
    },
    {
      "code": "DRUG-SIGN",
      "severity": "critical",
      "task": "Obtain two conflict-screened independent pharma/regulatory and statistical reviews; externally timestamp exact locked criteria."
    }
  ],
  "external_roles_needed": [
    "Independent clinical development / US FDA regulatory methods specialist",
    "Independent medicinal chemist experienced in AI molecular design attribution"
  ],
  "primary_sources": [
    "https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026",
    "https://insilico.com/news/isn1009261-insilico-medicine-doses-first-patient-genesis-ipf-3",
    "https://www.nature.com/articles/s41573-026-01496-2"
  ],
  "lock_status": "NOT_READY_TO_LOCK",
  "scoring_eligible": false,
  "public_reviewer_contact": "https://cortist.com/contact/",
  "no_retroactive_lock": true,
  "versioned_prior_workpaper": "/data/forecasts/calibration/m-001-working-20261023.json"
}