Yes — results are overdue. Primary completion was 2018-02-05; the FDAAA-801 reporting deadline (2019-02-05) passed 2739 days ago and no results are posted on ClinicalTrials.gov.
| NCT ID | NCT03251339 ↗ |
|---|---|
| Sponsor | Fresenius Kabi SwissBioSim GmbH (INDUSTRY) |
| Phase | PHASE1 |
| Status | COMPLETED |
| Primary completion | 2018-02-05 (ACTUAL) |
| Reporting deadline | 2019-02-05 (completion + 365d) |
| Days overdue | 2739 |
| Results posted | No — check results tab ↗ |
| FDA-regulated | drug: yes, device: no |
| Provenance | Flagged overdue on 2026-06-21 · SHA-256 31387fc1b14b4175… (hash-chained, tamper-evident) |
Source of record: ClinicalTrials.gov NCT03251339. The reporting requirement is FDAAA 801 (Public Law 110-85 §801) and the Final Rule, 42 CFR Part 11.