Source of truth: docs/AWAITING_CLINICAL_VALIDATION.md
Awaiting external clinical validation
This page restates docs/AWAITING_CLINICAL_VALIDATION.md. The simulator does not validate itself as a cure, a Phase II result, or FDA/EMA readiness.
What is complete here (research)
- Mechanistic closed loop: observations → controller A/B/E/F → unitless
U→ PK/PD → CancerODE (LSODA) - Disease taxonomy + immune/antibody readiness (state signatures, not TNM)
- In-silico endpoint mapping with computed statistics
- Scientific visualization: flybody fruitfly.xml + Blender sidecar / HUD
- Honesty package: DISCLAIMER.md, MERGE_READINESS.md
What happens next (external)
Partners and reviewers — not this git repo — own:
- IRB / ethics review for any human-data protocol
- Wet-lab / preclinical models that can falsify the ODE
- Clinical trials (Phase I → III) only if independent evidence supports that path
- Regulatory submissions if a product is ever proposed
None of those artifacts are produced by pytest or by a virtual cohort.
What this project will not claim while awaiting that gate
- Cure, disease eradication, or a treatment path
- FDA / EMA readiness or a cleared medical device
- A real Phase I / II / III result
- That a log-rank p or Cox HR on a virtual cohort is a clinical effect
- That F-256 (or 166k) “thinks,” synthesizes biologics, or doses patients
Until an external lab, IRB, and trial apparatus exist, Confluence remains a research codebase.