── Diligence workbench ──

aducanumab· Biogen / Eisai

Contested-approval retrospective. Information cutoff: March 2019, immediately after Biogen halted ENGAGE/EMERGE Phase 3 trials for futility. Framework should report a low LOA. The actual outcome — FDA accelerated approval in June 2021 over the AdCom's 10-0 reject vote — is a political-process outcome the framework can't and shouldn't predict. Useful for testing how the framework handles a controversial Phase 3 readout.

Asset ▸phase 3 · cns · monoclonal antibody · well capitalized · 1 designation · 2 competitors[ edit ]

Asset name

Sponsor

Phase

Therapeutic area

Modality

Mechanism

Supply constraint (manufacturing / raw material)

Target validated by prior approval

Biomarker-enriched trial

Direct competitors in this indication: 2

Regulatory designations

── Risk & limits ─────────────────────────

Q: what could break this thesis?

Known limitations

Rare disease (small N)
BIO/Informa rare-disease base rate (~16% from P1) is built on a small population of approvals. Cumulative LOA estimates are noisier for indications with <20 historical approvals.
Platform companies
Single-asset LOA doesn't capture portfolio effects. A platform with 6 correlated programs has a different risk profile than 6 independent shots-on-goal. v2 portfolio view addresses this.
China-origin assets
BIO base rates reflect FDA/EMA cohorts. NMPA development paths differ; cross-jurisdictional risk profiles are not yet modeled. Treat outputs as US/EU-only.
Pre-2018 capital-position data
Reflexivity multipliers are calibrated to post-2018 trial-design and biomarker-enrichment norms. Older comparables may understate the gap between well-capitalized and constrained sponsors.

Game-Theory Adversary · agent

Waiting for PoS / rNPV / scorecard / comparables…