Yes — results are overdue. Primary completion was 2018-05-08; the FDAAA-801 reporting deadline (2019-05-08) passed 2647 days ago and no results are posted on ClinicalTrials.gov.
| NCT ID | NCT03251248 ↗ |
|---|---|
| Sponsor | Fresenius Kabi SwissBioSim GmbH (INDUSTRY) |
| Phase | PHASE1 |
| Status | COMPLETED |
| Primary completion | 2018-05-08 (ACTUAL) |
| Reporting deadline | 2019-05-08 (completion + 365d) |
| Days overdue | 2647 |
| Results posted | No — check results tab ↗ |
| FDA-regulated | drug: yes, device: no |
| Provenance | Flagged overdue on 2026-06-21 · SHA-256 76984811810b5ca2… (hash-chained, tamper-evident) |
Source of record: ClinicalTrials.gov NCT03251248. The reporting requirement is FDAAA 801 (Public Law 110-85 §801) and the Final Rule, 42 CFR Part 11.