Evidence is the price of saying anything publicly.

Novel Biotech has no scientific program and no result of its own. The register lists the few primary sources that currently matter to future diligence, what each supports, and what it does not.

factplanhypothesisambition

Four records. Every limit visible.

SRC-LU-2020factneeds human review

Peer-reviewed primary research

Reprogramming to recover youthful epigenetic information and restore vision

Open primary source ↗

Supports: AAV2-delivered OSK showed retinal/visual restoration effects in the reported mouse experiments.
Model / population: Mouse retinal and optic-nerve models
Relevance: Supports biological plausibility for carefully bounded program diligence.
Does not support: Not human efficacy, not a clinical safety result, and not evidence that Novel Biotech owns or can execute a program.
Review: Automated source triage; qualified review pending
Provenance: docs/roadmap/SOURCE_REGISTER.md#SRC-LU-2020

SRC-ER100-TRIALfactneeds human review

Clinical trial registry

ER-100 for optic neuropathies — NCT07290244

Open primary source ↗

Supports: ER-100 is listed as a recruiting Phase 1 study with no posted results.
Model / population: Human Phase 1 study
Relevance: Establishes an active competitor and raises differentiation and freedom-to-operate questions.
Does not support: Recruiting status is not efficacy, safety, field ownership, or validation of a Novel Biotech program.
Review: Automated source triage; qualified review pending
Provenance: docs/roadmap/SOURCE_REGISTER.md#SRC-ER100-TRIAL

SRC-FDA-PRECLINICALfactneeds human review

Regulatory guidance

Preclinical assessment of investigational cellular and gene therapy products

Open primary source ↗

Supports: Gene-therapy development requires a structured preclinical evidence and safety package.
Model / population: Regulated development framework
Relevance: Defines questions a future program must answer before clinical work.
Does not support: Guidance is not approval, endorsement, or evidence that any proposed program is ready.
Review: Automated source triage; qualified review pending
Provenance: docs/roadmap/SOURCE_REGISTER.md#SRC-FDA-PRECLINICAL

SRC-PMDA-CONSULTfactneeds human review

Regulatory authority guidance

PMDA consultations

Open primary source ↗

Supports: PMDA provides formal consultation pathways relevant to regulated development in Japan.
Model / population: Regulated development framework
Relevance: Frames the founder’s tentative Japan-first sequence as a diligence question, not a shortcut.
Does not support: A consultation pathway is not approval and does not establish the correct entity or development sequence.
Review: Automated source triage; qualified review pending
Provenance: docs/roadmap/SOURCE_REGISTER.md#SRC-PMDA-CONSULT

concept study

MF-01 turns one speculative question into something you can inspect.

The study sets out its source boundaries, failure modes, and stop conditions. It is not a program, product, prototype, or device.

Open the MF-01 study

preserved demonstration

The Observatory still runs. It is not Novel Biotech.

It is a synthetic software demonstration from an earlier direction, with authored fixture data, simulated review history, and scores that mean nothing outside the demo. It is preserved as history, not as research evidence.

Open the preserved Observatory