m625 is not a clinical decision tool · not a publisher · not an expert authority · not a simulator. It is a cross-domain Roll-formalized evidence atlas with public audit + attack surface.
Why a regulator-adjacent reviewer would come (cancer-specific)
A FDA / EMA / NMPA reviewer looking at oncology submissions reads sponsor decks with embedded "audit framework" claims. The question is: what does a real cross-period audit trail look like, structurally? m612's 5/12 delivered Harvard dossier is a concrete worked example of a frozen audit-trail at the cancer-domain level — informational, not regulatory.
Pain points:
sponsor "audit-grade" claims are mostly marketing;
cross-period frozen dossiers are rare;
the frozen property (v1.2 FROZEN means: changes after the freeze date require explicit unfreeze) is hard to find in sponsor literature.
m625 does not advise on regulatory submissions. **m625 shows what `m612 v1.2 FROZEN` means structurally and how a frozen-dossier discipline could inform regulator review** — informational only.
This is not regulatory advice. This is not a submission template.
The Roll-formalized object (anchored on m612 v1.2 FROZEN + m610 audit-pass record)
Field
Value
Upstream frozen dossier
m612 (Harvard 2026-05-12 Cancer Dynamics Discussion · 5/12 delivered) v1.2 FROZEN per 01_materials_cache/A6_m612_dossier_summary.md
Frozen property
post-freeze changes require explicit unfreeze action; no silent edits
structural-analog to regulator multi-stage review (informational only · per i_demo_008)
Cross-period K4.1 declarations
three distinct K4.1 bit patterns in the three base cases: (0,1,1) · (1,1,0) · (1,1,1)
How a regulator reviewer should read (≤ 5 minutes)
The frozen discipline. A submission dossier that is frozen at a specific date with explicit unfreeze requirements is structurally different from a continuously-updated literature review. m612 v1.2 FROZEN is one worked example.
The audit-pass record. Each cooked case has an audit-pass score (manual + machine) and a known v0.1 → v0.2 patch history (e.g., case_150 had an F3 hard-veto fix · per m604 V2.6 Framework §4.3). Sponsor submissions with similar audit-trail transparency are structurally stronger.
The K4.1 declaration as cross-period spec. For an oncology submission claiming long-term outcome (≥ 1 yr OS / PFS), the K4.1 3-bit declaration (X / Φ / Δ-B visible alterations) gives a structural way to specify what the claim covers — independent of any specific endpoint definition.
What this is NOT. It is not a regulatory pathway recommendation. It is not an evaluation of any specific oncology submission. It is informational reference for thinking about audit-trail structure.
What this demo will not say (anti-drift)
❌ It does not assess any specific FDA / EMA / NMPA review pathway.
❌ It does not recommend any sponsor adopt Roll as a regulatory standard.
❌ It does not name or rank any specific oncology submission.
❌ It does not affirm or vouch for any review-board member or sponsor (m517 W7-N inheritance).
❌ It does not use cure / reverse / 100% effective / revolutionary lexicon.
Cross-domain transferability declaration (W6.3)
The frozen-dossier + audit-pass-record discipline is structurally applicable across domains (cancer / neuro / rare). transferability_pct: structural-analog only; substantive cross-domain regulatory framework still requires per-domain regulator engagement. m625 does not assert quantitative cross-domain regulatory equivalence.
Falsifying prediction
The "frozen-dossier discipline informs structural audit-trail thinking" claim is falsified by:
a regulator-side review of m612 v1.2 FROZEN structure that concludes the frozen-discipline does not map structurally to regulatory review primitives (i.e., the analogy is misleading);
a sponsor adopting frozen-dossier discipline and still receiving structural audit-trail findings from a regulator review.
Attack surface entries
AS-001 (cure cancer regulatory-context smuggle) — G2.2
AS-024 (state-of-the-art marketing in regulatory-context) — G2.2
Ferry target
m560 (gov_rfc for cross-project frozen-dossier discipline) · m622 (conf_pack for regulator-adjacent conference informational session).
Honest verdict (W6.5)
已做: regulator × cancer audit-trail framing · m612 v1.2 FROZEN structural example · 3 attack-surface refs · falsifying prediction with two paths.
待办: explicit cross-mapping to a specific regulator framework (FDA Center for Drug Evaluation review primitives, etc.) — open work; requires regulator-side input.
漏洞: m612 v1.2 FROZEN audit scores are training_data_recall · TODO_unverified per cache; live re-audit is m612 sovereign. Structural-analog to regulator review is asserted at framework level only.
反驳预案:
- *"This is sponsor-friendly framing."* — No · sponsor-friendly would assert sponsor benefit. This says sponsor-side audit-trail discipline is *structurally* more legible to regulator review, which cuts both ways.
- *"Why anchor on Harvard 2026-05-12 specifically?"* — Because it's a concrete worked example with a stamped freeze date and a public delivery milestone. Other frozen dossiers may serve the same purpose.