Development Path Templates
Development paths are model-structure templates under an asset/program's indication plan. They classify whether a plan is baseline, a structural template, analyst-confirmed, or display-only. The path label itself does not change probability of success, revenue, cost, duration, or launch timing; only explicit, visible, cited assumptions can change scenario math.
01What development paths mean
A path is structure and disclosure, not hidden valuation math.
Development paths sit under an asset/program's indication plan: Asset / Program → Indication Plan → Development Path → Scenario. The path records the planned clinical/regulatory route for one indication, patient segment, geography, or branch.
The path label itself has no numeric force. It tells a reviewer what has to be checked before a scenario can apply launch timing, cost, revenue, or population effects. Those effects must be explicit, visible, and cited at the branch or scenario level.
02Automatic-effect policy
No development path currently earns a path-based PoS multiplier.
Governance rule
Path labels do not change probability of success, revenue, cost, duration, or launch timing by default. Unsupported branch-effect keys are stripped before application, including any attempted path-based PoS multiplier.
The evidence base supports treating these routes as different regulatory and clinical-development structures. It does not support a universal, indication-agnostic numeric uplift or haircut just because a label says accelerated, adaptive, basket, bridging, or expansion.
03Tier policy
The tier tells reviewers how much automatic meaning the template is allowed to carry.
| Tier | Automatic policy | Meaning |
|---|---|---|
| Baseline | No default effect | The comparator path. It supplies ordinary sequencing metadata and does not change valuation assumptions. |
| Structural template | Explicit structural only | The template exposes required review fields and structural flags, but numeric effects remain empty unless entered explicitly. |
| Analyst-confirmed | Analyst confirmed only | The literature supports the path as a distinct clinical design, but effects are bidirectional and asset-specific. |
| Display-only | No default effect | Custom narrative/organization only. It has no model effect until every assumption is entered with rationale. |
04Path templates
Allowed meaning and prohibited default effects for each shipped template.
| Path type | Tier | May do | May not do by default |
|---|---|---|---|
| standard_sequential | Baseline | Records the ordinary phase sequence and serves as the no-path-effect comparator. | No path-specific PoS, timing, revenue, or cost effect. |
| accelerated_approval | Structural template | Records accelerated-approval structure, confirmatory obligation, surrogate-endpoint basis, and withdrawal exposure. | No generic launch pull-forward, PoS uplift, commercial haircut, or confirmatory-trial cost default. |
| label_expansion | Structural template | Records supplemental filing structure and requires incremental population/revenue net of the base indication. | No automatic revenue uplift, PoS uplift, or exclusivity benefit. |
| adaptive_design | Analyst-confirmed | Records interim decision rules, enrichment, sample-size re-estimation, or population narrowing. | No automatic cost reduction, duration reduction, sample-size effect, or PoS effect. |
| basket_or_umbrella | Analyst-confirmed | Records multi-cohort structure, common-control logic, cohort pruning, and registration-supporting cohort assumptions. | No automatic market-size haircut, cohort attrition, revenue change, cost change, or tumor-agnostic filing effect. |
| bridging_or_regional | Analyst-confirmed | Records geography, foreign-data package, regional bridge requirement, MRCT context, and partner-led assumptions. | No automatic regional launch acceleration, revenue haircut, bridge-study cost, or probability effect. |
| custom | Display-only | Stores a user-defined route for disclosure and branch organization. | No effect of any kind until the analyst enters explicit assumptions. |
05Evidence rationale
Source support is structural; numeric defaults require separate validation.
FDA guidance describes accelerated approval, adaptive designs, and master protocols as clinical-development routes with design-specific obligations and evidentiary requirements. Supplemental-indication and multi-indication oncology studies show that approval routes and post-approval timelines vary materially across products.
That is enough to make development paths meaningful as model-structure templates. It is not enough to ship a generic path-based PoS, duration, revenue, or cost multiplier. Future numeric defaults would require a new version, a cited estimand, and a held-out validation gate comparable to the PoS multiplier discipline.
06Signed-export disclosure
Reviewers should see the path policy before trusting the number.
Machine and signed-export surfaces should expose the path label, tier, automatic effect policy, explicit branch effects, analyst overrides, and citations. If no explicit effect exists, the path is disclosure-only.
This keeps path semantics useful without forcing a reviewer to infer whether a hidden adjustment changed the scenario output. The numeric model remains deterministic and inspectable: branch effects are visible inputs, not label side effects.