Yes — results are overdue. Primary completion was 2017-09-01; the FDAAA-801 reporting deadline (2018-09-01) passed 2850 days ago and no results are posted on ClinicalTrials.gov.
| NCT ID | NCT03664401 ↗ |
|---|---|
| Sponsor | Kerecis Ltd. (INDUSTRY) |
| Phase | EARLY_PHASE1 |
| Status | COMPLETED |
| Primary completion | 2017-09-01 (ACTUAL) |
| Reporting deadline | 2018-09-01 (completion + 365d) |
| Days overdue | 2850 |
| Results posted | No — check results tab ↗ |
| FDA-regulated | drug: yes, device: yes |
| Provenance | Flagged overdue on 2026-06-21 · SHA-256 1a3169d22be6a1f8… (hash-chained, tamper-evident) |
Source of record: ClinicalTrials.gov NCT03664401. The reporting requirement is FDAAA 801 (Public Law 110-85 §801) and the Final Rule, 42 CFR Part 11.