Clinical efficacy strength
Endpoint quality, effect size, statistical robustness, and translational relevance.
What we evaluate
Twelve evaluation areas, reasoned together.
Each area is scored, flagged, and tied back to the asset verdict and deal implications.
Safety signal risk
Treatment-related events, class effects, and labeling exposure.
CMC readiness
Process maturity, comparability, supply, and inspection readiness.
Nonclinical package adequacy
Tox program completeness and bridging strategy gaps.
Regulatory precedent
Comparable approvals, advisory committee history, and pathway signals.
Comparator quality
Standard of care alignment and competitive evidence framing.
Endpoint defensibility
Clinical meaningfulness and regulatory acceptability of endpoints.
Labeling risk
Anticipated indication scope, boxed warnings, and contraindications.
FDA interaction history
Meeting minutes signals, IND holds, and prior agency feedback.
Approval pathway clarity
Accelerated, traditional, breakthrough, and orphan considerations.
Commercial differentiation
Profile vs. emerging competitors and access positioning.
Deal structure implications
Milestone, CVR, and option-to-buy structures aligned to risk.
Before the term sheet
Understand the asset risk before you commit capital.
A short conversation is enough to scope a meaningful diligence review, tailored to your asset stage and decision window.
No confidential information required to start the conversation.