{
  "question_id": "W241",
  "slug": "drug-approved-within-a-year-of-first-dose",
  "title": "A drug wins full approval within a year of its first human dose",
  "type": "binary",
  "resolution": {
    "levels": [],
    "values": [],
    "annotations": []
  },
  "forecasts": [
    {
      "question_id": "W241",
      "forecast_date": "2026-09-20",
      "evidence_cutoff": "2026-09-20",
      "method": "wide-v2",
      "opened": "2026-09-16",
      "linked_questions": [],
      "reading_adopted": null,
      "summary": null,
      "ambiguities": [],
      "key_drivers": [],
      "would_update_on": [],
      "forecasts": [
        {
          "period_end": "2026-09-30",
          "p_yes": 0.0001
        },
        {
          "period_end": "2026-12-31",
          "p_yes": 0.001
        },
        {
          "period_end": "2027-03-31",
          "p_yes": 0.002498
        },
        {
          "period_end": "2027-06-30",
          "p_yes": 0.003995
        },
        {
          "period_end": "2027-09-30",
          "p_yes": 0.005489
        },
        {
          "period_end": "2027-12-31",
          "p_yes": 0.00698
        },
        {
          "period_end": "2028-03-31",
          "p_yes": 0.009463
        },
        {
          "period_end": "2028-06-30",
          "p_yes": 0.011939
        },
        {
          "period_end": "2028-09-30",
          "p_yes": 0.014409
        },
        {
          "period_end": "2028-12-31",
          "p_yes": 0.016873
        },
        {
          "period_end": "2029-03-31",
          "p_yes": 0.020806
        },
        {
          "period_end": "2029-06-30",
          "p_yes": 0.024723
        },
        {
          "period_end": "2029-09-30",
          "p_yes": 0.028624
        },
        {
          "period_end": "2029-12-31",
          "p_yes": 0.032509
        },
        {
          "period_end": "2030-03-31",
          "p_yes": 0.038314
        },
        {
          "period_end": "2030-06-30",
          "p_yes": 0.044084
        },
        {
          "period_end": "2030-09-30",
          "p_yes": 0.04982
        },
        {
          "period_end": "2030-12-31",
          "p_yes": 0.055521
        },
        {
          "period_end": "2031-03-31",
          "p_yes": 0.063077
        },
        {
          "period_end": "2031-06-30",
          "p_yes": 0.070572
        },
        {
          "period_end": "2031-09-30",
          "p_yes": 0.078008
        }
      ],
      "passes": []
    },
    {
      "question_id": "W241",
      "forecast_date": "2026-09-27",
      "evidence_cutoff": "2026-09-27",
      "method": "wide-v2",
      "opened": "2026-09-16",
      "linked_questions": [],
      "reading_adopted": "A newly published final qualifying document may establish an earlier approval, but the original worldwide first-human-dose clock never restarts; I do not require the approval action itself to postdate opening.",
      "summary": null,
      "ambiguities": [],
      "key_drivers": [],
      "would_update_on": [],
      "forecasts": [
        {
          "period_end": "2026-09-30",
          "p_yes": 0.0001
        },
        {
          "period_end": "2026-12-31",
          "p_yes": 0.0005
        },
        {
          "period_end": "2027-03-31",
          "p_yes": 0.0011
        },
        {
          "period_end": "2027-06-30",
          "p_yes": 0.001799
        },
        {
          "period_end": "2027-09-30",
          "p_yes": 0.002597
        },
        {
          "period_end": "2027-12-31",
          "p_yes": 0.003495
        },
        {
          "period_end": "2028-03-31",
          "p_yes": 0.004492
        },
        {
          "period_end": "2028-06-30",
          "p_yes": 0.005686
        },
        {
          "period_end": "2028-09-30",
          "p_yes": 0.007078
        },
        {
          "period_end": "2028-12-31",
          "p_yes": 0.008667
        },
        {
          "period_end": "2029-03-31",
          "p_yes": 0.01065
        },
        {
          "period_end": "2029-06-30",
          "p_yes": 0.012925
        },
        {
          "period_end": "2029-09-30",
          "p_yes": 0.015492
        },
        {
          "period_end": "2029-12-31",
          "p_yes": 0.018445
        },
        {
          "period_end": "2030-03-31",
          "p_yes": 0.02188
        },
        {
          "period_end": "2030-06-30",
          "p_yes": 0.025793
        },
        {
          "period_end": "2030-09-30",
          "p_yes": 0.030177
        },
        {
          "period_end": "2030-12-31",
          "p_yes": 0.035026
        },
        {
          "period_end": "2031-03-31",
          "p_yes": 0.040333
        },
        {
          "period_end": "2031-06-30",
          "p_yes": 0.046091
        },
        {
          "period_end": "2031-09-30",
          "p_yes": 0.052292
        }
      ],
      "passes": []
    },
    {
      "question_id": "W241",
      "forecast_date": "2026-09-30",
      "evidence_cutoff": "2026-09-30",
      "method": "wide-v2.1",
      "opened": "2026-09-16",
      "linked_questions": [],
      "reading_adopted": "Read literally: requires a CDER-listed novel drug's traditional approval dated no later than the first anniversary of its documented worldwide first human dose; CBER individualized gene-editing approvals and variants added by supplement (not on CDER's novel list) do not count.",
      "summary": null,
      "ambiguities": [],
      "key_drivers": [],
      "would_update_on": [],
      "forecasts": [
        {
          "period_end": "2026-09-30",
          "p_yes": 0.0002
        },
        {
          "period_end": "2026-12-31",
          "p_yes": 0.0009
        },
        {
          "period_end": "2027-03-31",
          "p_yes": 0.0019
        },
        {
          "period_end": "2027-06-30",
          "p_yes": 0.0029
        },
        {
          "period_end": "2027-09-30",
          "p_yes": 0.0039
        },
        {
          "period_end": "2027-12-31",
          "p_yes": 0.0049
        },
        {
          "period_end": "2028-03-31",
          "p_yes": 0.0063
        },
        {
          "period_end": "2028-06-30",
          "p_yes": 0.0077
        },
        {
          "period_end": "2028-09-30",
          "p_yes": 0.0091
        },
        {
          "period_end": "2028-12-31",
          "p_yes": 0.0105
        },
        {
          "period_end": "2029-03-31",
          "p_yes": 0.0122
        },
        {
          "period_end": "2029-06-30",
          "p_yes": 0.014
        },
        {
          "period_end": "2029-09-30",
          "p_yes": 0.0158
        },
        {
          "period_end": "2029-12-31",
          "p_yes": 0.0176
        },
        {
          "period_end": "2030-03-31",
          "p_yes": 0.0198
        },
        {
          "period_end": "2030-06-30",
          "p_yes": 0.0221
        },
        {
          "period_end": "2030-09-30",
          "p_yes": 0.0243
        },
        {
          "period_end": "2030-12-31",
          "p_yes": 0.0266
        },
        {
          "period_end": "2031-03-31",
          "p_yes": 0.0293
        },
        {
          "period_end": "2031-06-30",
          "p_yes": 0.032
        },
        {
          "period_end": "2031-09-30",
          "p_yes": 0.0347
        }
      ],
      "passes": []
    },
    {
      "question_id": "W241",
      "forecast_date": "2026-10-07",
      "evidence_cutoff": "2026-10-07",
      "method": "wide-v2.1",
      "opened": "2026-09-16",
      "linked_questions": [],
      "reading_adopted": null,
      "summary": "No new medicine has ever won full American approval within a year of its first dose in a person. Even in past health emergencies, the fastest took about 20 to 26 months. Faster reviews, single-study approvals and a pathway for custom genetic medicines make a record possible but unlikely: about 3% by 2031. The biggest change would be a company seeking approval for a one-patient genetic medicine within months of first treating that patient.",
      "ambiguities": [],
      "key_drivers": [],
      "would_update_on": [],
      "forecasts": [
        {
          "period_end": "2026-12-31",
          "p_yes": 0.0003
        },
        {
          "period_end": "2027-03-31",
          "p_yes": 0.0008
        },
        {
          "period_end": "2027-06-30",
          "p_yes": 0.0014
        },
        {
          "period_end": "2027-09-30",
          "p_yes": 0.0021
        },
        {
          "period_end": "2027-12-31",
          "p_yes": 0.0029
        },
        {
          "period_end": "2028-03-31",
          "p_yes": 0.0039
        },
        {
          "period_end": "2028-06-30",
          "p_yes": 0.005
        },
        {
          "period_end": "2028-09-30",
          "p_yes": 0.0062
        },
        {
          "period_end": "2028-12-31",
          "p_yes": 0.0075
        },
        {
          "period_end": "2029-03-31",
          "p_yes": 0.009
        },
        {
          "period_end": "2029-06-30",
          "p_yes": 0.0106
        },
        {
          "period_end": "2029-09-30",
          "p_yes": 0.0122
        },
        {
          "period_end": "2029-12-31",
          "p_yes": 0.014
        },
        {
          "period_end": "2030-03-31",
          "p_yes": 0.0159
        },
        {
          "period_end": "2030-06-30",
          "p_yes": 0.0179
        },
        {
          "period_end": "2030-09-30",
          "p_yes": 0.0199
        },
        {
          "period_end": "2030-12-31",
          "p_yes": 0.0221
        },
        {
          "period_end": "2031-03-31",
          "p_yes": 0.0243
        },
        {
          "period_end": "2031-06-30",
          "p_yes": 0.0267
        },
        {
          "period_end": "2031-09-30",
          "p_yes": 0.0291
        },
        {
          "period_end": "2031-12-31",
          "p_yes": 0.0316
        }
      ],
      "passes": []
    },
    {
      "question_id": "W241",
      "forecast_date": "2026-10-14",
      "evidence_cutoff": "2026-10-14",
      "method": "wide-v2.1",
      "opened": "2026-09-16",
      "linked_questions": [],
      "reading_adopted": null,
      "summary": "No new drug has ever won full FDA approval within a year of its first human dose. The fastest, Paxlovid, took about 2.3 years even during COVID, and no current candidate is close. Recent FDA reforms for custom genetic medicines and faster reviews make a record-breaking case conceivable by 2031, so I put the chance at about 2%. What would most change this is a company seeking approval of a custom RNA drug within months of first dosing a patient.",
      "ambiguities": [],
      "key_drivers": [],
      "would_update_on": [],
      "forecasts": [
        {
          "period_end": "2026-12-31",
          "p_yes": 0.0002
        },
        {
          "period_end": "2027-03-31",
          "p_yes": 0.0006
        },
        {
          "period_end": "2027-06-30",
          "p_yes": 0.0012
        },
        {
          "period_end": "2027-09-30",
          "p_yes": 0.002
        },
        {
          "period_end": "2027-12-31",
          "p_yes": 0.0029
        },
        {
          "period_end": "2028-03-31",
          "p_yes": 0.0039
        },
        {
          "period_end": "2028-06-30",
          "p_yes": 0.005
        },
        {
          "period_end": "2028-09-30",
          "p_yes": 0.0062
        },
        {
          "period_end": "2028-12-31",
          "p_yes": 0.0074
        },
        {
          "period_end": "2029-03-31",
          "p_yes": 0.0087
        },
        {
          "period_end": "2029-06-30",
          "p_yes": 0.01
        },
        {
          "period_end": "2029-09-30",
          "p_yes": 0.0112
        },
        {
          "period_end": "2029-12-31",
          "p_yes": 0.0125
        },
        {
          "period_end": "2030-03-31",
          "p_yes": 0.0139
        },
        {
          "period_end": "2030-06-30",
          "p_yes": 0.0153
        },
        {
          "period_end": "2030-09-30",
          "p_yes": 0.0167
        },
        {
          "period_end": "2030-12-31",
          "p_yes": 0.018
        },
        {
          "period_end": "2031-03-31",
          "p_yes": 0.0195
        },
        {
          "period_end": "2031-06-30",
          "p_yes": 0.021
        },
        {
          "period_end": "2031-09-30",
          "p_yes": 0.0225
        },
        {
          "period_end": "2031-12-31",
          "p_yes": 0.0239
        }
      ],
      "passes": []
    }
  ],
  "declined": []
}