Claude Skill

fda-catalyst-medicines

CDER-track catalyst analysis for medicines: PDUFA target dates, AdCom votes, sNDA/sBLA label expansions, biosimilar interchangeability and 180-day exclusivity, Orange Book state, and CRL remediation timelines — enumerated, verified, and sized per event for any biotech/pharma tick

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Part of agentii-ai/agentii-investment-intelligence — 46 skills

Install

skills CLI npx skills add https://github.com/agentii-ai/agentii-investment-intelligence/tree/main/plugins/vertical-plugins/bio-pharm/skills/agentii/fda-catalyst-medicines
Claude Code claude plugin marketplace add https://llmmart.ai/marketplace.json && claude plugin install agentii-ai-agentii-investment-intelligence@llmmart
Git git clone https://github.com/agentii-ai/agentii-investment-intelligence.git

The skills CLI installs just this skill, for any of its supported agents. Claude Code installs the whole agentii-ai/agentii-investment-intelligence collection as a plugin from our marketplace. Git is the plain clone.

Skill manifest

Methodology inspired by publicly taught biotech catalyst frameworks; all text is an original paraphrase.

Defaults

Parameter Default Value Rationale
forward_window_quarters 4 Standard catalyst window; extend to 8 on request
include_superseded false Active-only events by default; supersede chains on request
exclusivity_tracking true Orange Book and 180-day exclusivity state attached to launch-relevant events
holiday_labeling true Holiday-shifted weeks flagged on every calendar row
horizon_days 180 Default for get_upcoming_pdufa horizon

Preflight

Run canonical pre-flight per contracts/preflight.md. Propagate X-Agentii-Trace per contracts/x-agentii-trace-header.md. Confirm ticker resolution via search_companies before catalyst queries.

Triggers

  • "When is the PDUFA date for [drug/ticker]?"
  • "What AdCom meetings are coming up for [ticker]?"
  • "Has [drug]'s sNDA/sBLA label expansion been approved?"
  • "Which biosimilars have interchangeability designation, and when does 180-day exclusivity run?"
  • "What is [drug]'s Orange Book patent and exclusivity state?"
  • "How is [ticker]'s CRL remediation timeline shaping up?"
  • "Build a PDUFA/AdCom calendar for my pharma watchlist."
  • "Evaluate the approval odds for [drug] ahead of its AdCom."
  • "What label expansions are pending for [ticker] this year?"
  • "Which medicine decisions land this quarter?"
  • "How do biosimilar launches erode the reference product's share?"
  • "Which catalysts overlap with [ticker]'s earnings date?"

Production Grounding

  • CDER mechanics: NDA/BLA review tracks, PDUFA target dates, priority review, breakthrough designation, accelerated approval, CRL deficiency classes and the remediation reset, AdCom vote patterns.
  • Label expansions (sNDA/sBLA) are the commercial catalysts beyond first approval; Orange Book patent and exclusivity state sets the generic or biosimilar entry window.
  • Biosimilar timeline note: interchangeability plus 180-day exclusivity for the first interchangeable delays competing entry — and approval is not launch; commercial timing follows exclusivity expiry and patent-settlement terms.
  • Holiday-week labeling discipline: comps across holiday-shifted weeks are noisy; every calendar row carries its caveat, and holiday weeks are labeled explicitly.
  • Apply AdCom-style scrutiny axes when framing outcome odds; never fabricate dates, votes, or outcomes — annotate coverage gaps instead (per references/knowledge-frameworks.md).

Data Source Priority

  1. Structured catalyst data: get_upcoming_pdufa / get_pdufa_decision (pipeline.fda_calendar_event).
  2. AdCom and approval history: search_adcom_meetings / get_adcom_meeting; search_fda_approvals / get_fda_approval.
  3. Company and filing context: get_company_profile, search_documents, search_sec_filings; briefing docs via list_sources(source_type=adcom_briefing) + read_source_outline/read_source_pages with meeting slugs.
  4. Historical grounding: search_investment_cases (event_type=adcom_vote/pdufa_decision/crl/approval), search_by_analogue, search_investment_strategies (sectors=med).
  5. Earnings overlap: search_earnings_calendar / list_upcoming_earnings.

Methodology

Retrieval Scope

unstructured_document_search

Retrieval Strategy

  1. Resolve ticker(s) via search_companies; note primary drug/application names.
  2. Pull active PDUFA events (get_upcoming_pdufa, horizon_days=default); layer AdCom meetings and earnings dates.
  3. Per event: decision history (get_pdufa_decision by drug/application), approval record (get_fda_approval), label and Orange Book state.
  4. For AdCom events, retrieve briefing documents via list_sources + read_source_outline/read_source_pages using meeting slugs; apply scrutiny axes.
  5. Ground the play in knowledge: search_investment_cases / search_by_analogue with med filters; cite /v/ records.

Temporal Scope

See frontmatter temporal_scope block. Exclusivity windows may require looking back up to 8 quarters when requested.

Tool Allowlist

See frontmatter allowed_tools.

Protocol

  1. Ticker resolution
  2. Catalyst enumeration (PDUFA / AdCom / label expansion / exclusivity events)
  3. Per-event outcome framing (scrutiny axes + decision history)
  4. Historical analogue retrieval
  5. Calendar synthesis + exclusivity and risk flags

Modes

  • Watchlist (default, multi-ticker): one dated calendar with per-ticker sections, sorted by date.
  • Single ticker deep-dive: full event timeline, per-event probability framing, label and exclusivity state.
  • Event type: restrict to PDUFA / AdCom / label expansion / biosimilar milestones on request.
  • Exclusivity scan: Orange Book and 180-day windows as the launch-timing lens.

Tool Fallbacks

Failure Fallback
get_upcoming_pdufa empty Search filings (search_documents keyword PDUFA) + search_sec_filings 8-Ks; annotate coverage_gap
AdCom briefing path 404 search_documents with source_institution filter; degrade to calendar metadata
Knowledge tools empty Proceed with structured data only; annotate knowledge coverage_gap
Orange Book state unknown Flag exclusivity window unavailable; never infer expiry dates

Output File

{ticker}/{YYYY-MM-DD_HHMM}_fda-catalyst-medicines_{affix}.md (watchlist: watchlist/{YYYY-MM-DD_HHMM}_fda-catalyst-medicines-calendar_{affix}.md)

Output Structure

  1. Executive Summary — highest-impact CDER-track catalysts in the window, 2-3 sentences
  2. Catalyst Calendar — dated table: date, ticker, event type, drug, application, holiday-week flag, expected-impact framing
  3. Per-Event Analysis — scrutiny-axes assessment (safety/statistics/subgroups/benefit-risk) + decision history
  4. Label & Exclusivity State — sNDA/sBLA status, Orange Book state, 180-day windows, biosimilar entry timing
  5. Historical Analogues — matched cases with /v/ citations and quantified outcomes
  6. Risk Assessment & Coverage Gaps — binary-risk sizing, overlap clusters, unverified or missing data

Error Handling

Error Fallback
No PDUFA rows Fall back to earnings + AdCom + label events; annotate coverage_gap — never fabricate dates
Superseded dates Active-only by default; expose supersede chain via include_superseded=true
Ticker not in med universe Resolve via CIK/drug-universe match; surface the classification gap

Memory Load

See contracts/memory-load.md.

Snapshot

See contracts/snapshot-synthesis.md.

Final Summary (TUI)

Include ### Key Citations block with 0-10 clickable /v/ URLs.

References

  • contracts/citation-and-memory.md
  • contracts/output-frontmatter-schema.md
  • contracts/memory-load.md
  • contracts/snapshot-synthesis.md
  • contracts/preflight.md
  • references/knowledge-frameworks.md
Files (agentii-investment-intelligence)
  • references
    • knowledge-frameworks.md 5.1 KB 
      # FDA Catalyst Medicines — Knowledge Frameworks

Static grounding for `fda-catalyst-medicines` (spec 055). Runtime records (approved med strategies and cases) are retrieved via the knowledge tools and cited with /v/ URLs; this file carries the CDER pathway ladder, failure modes, and the pattern disciplines those records rest on. Shared regulatory scaffolding (FDA/EMA process, AdCom mechanics, the six scrutiny axes, catalyst sizing) lives in the fda-catalyst-analysis skill's reference: `../../fda-catalyst-analysis/references/knowledge-frameworks.md`.

## CDER Pathway Ladder

1. **Filing**: NDA (small molecules) or BLA (biologics) submitted; review track assigned — standard (~10 months) or priority (~6 months), with breakthrough designation enabling rolling review.
2. **Review + AdCom**: FDA reviewer analyses, sponsor briefings, advisory committee vote where the approval is ambiguous. The vote is advisory but moves the stock before the date.
3. **PDUFA target date**: the negotiated decision date — the anchor of any medicines catalyst calendar.
4. **Decision**: approval, Complete Response Letter (CRL — deficiencies listed; the sponsor's remediation resets the clock), or withdrawal.
5. **Label expansion**: sNDA/sBLA filings extend indications, populations, and formulations — the recurring catalyst stream after first approval.
6. **Loss of exclusivity (LOE)**: Orange Book patents and exclusivities (NCE, NCI, ODE, PTE) expire; generic or biosimilar entry follows the earliest expiry.

## Biosimilar Timeline Note

- Interchangeability is a designation, not an approval: a biosimilar can be approved but not interchangeable.
- The first interchangeable biosimilar earns 180-day exclusivity against other interchangeables — a genuine entry-window moat.
- Approval date is not launch date: launch sequencing follows patent-settlement terms, at-risk launches, and exclusivity expiry — size the launch catalyst, not the approval one.

## Failure Modes

- **Fabricated dates**: filling an empty tool response with an assumed PDUFA date — always annotate `coverage_gap` instead.
- **Treating an AdCom vote as the decision**: the vote is advisory; the decision lands on the PDUFA date.
- **Ignoring superseded dates**: a supersede chain is information — a pushed date re-times the whole calendar.
- **Ignoring exclusivity state**: a launch catalyst sized without Orange Book state misses the entry-window question.
- **Unlabeled holiday weeks**: week-over-week comparisons across holiday-shifted weeks read as signal when they are noise.
- **CRL remediation treated as free**: every remediation resets the target date and delays the cash-flow start.

## Methodology Patterns (original paraphrase of publicly taught practice)

### P4 event-takeaway anatomy (post-decision notes)

Headline verdict first → per-stock takeaways with model numbers → KOL distillation → raw data and cross-trial comparison lattices → modeled deltas vs consensus (peak x POS) → three what's-changed vectors (estimates / thesis / positioning) → upside/downside bullets. Conflicting KOL views are surfaced verbatim and rated by materiality — never silently averaged.

### P1 launch board (commercial context for post-approval catalysts)

Actual prescription share overlaid with at least two named same-class launch curves and a consensus-implied trajectory: consensus sales ÷ net price per script ÷ script duration → required weekly scripts → linear path vs actuals. LOE erosion: entrant share series and branded year-over-year decay side by side, approval and launch dates on the timeline.

### POS / scenario discipline (cross-cutting)

Unadjusted peak x probability of success = the modeled number; both terms shown. Every POS change is logged with its reason. Bull/base/bear always carries a named-driver assumption grid — never a single point number. Explicit abstention ("no view on likelihood") where unquantifiable.

## Structured Data Surfaces

- `get_upcoming_pdufa` / `get_pdufa_decision` — pipeline.fda_calendar_event rows (horizon_days default 180).
- `search_adcom_meetings` / `get_adcom_meeting` — committee/product/ticker/date/vote filters; briefing-doc inventory per meeting.
- `search_fda_approvals` / `get_fda_approval` — approval history with label and designation state.

## Cross-Cutting Habits

- **Buy-side lens**: track where investor attention sits; frame per-name bull/bear pivot conditions; the client-question pattern — surface the question most often asked about the event (e.g. "does the AdCom vote pre-empt the PDUFA?") and answer it directly.
- **Living-thesis loop**: estimates move first, ratings last; append new exhibits to the prior note, never rewrite; holiday labels persist across updates.
- **Badge mapping (FR-092)**: every output line carries a badge — verifiable facts `[FACT]`, arithmetic derived from facts `[DEDUCTED]`, judgments and interpretations `[VIEW]` — summarized in a Category/Count/% table.

## Authoring-time citations

Spec 055 med strategies and cases are linked here as they reach `approved` status; at runtime retrieve via `search_investment_strategies(sectors=med)` / `search_investment_cases` and cite with /v/ URLs.
    • modes.md 604 B 
      # fda-catalyst-medicines — Analyst Mode Definitions

Derived from the skill's ## Modes section (spec 046 M1).

### Mode: watchlist

**Objective**: One dated catalyst calendar with per-ticker sections, sorted by date.

### Mode: single-target

**Objective**: Full event timeline for one ticker with per-event probability framing and exclusivity state.

### Mode: event-type

**Objective**: Restrict coverage to one event class — PDUFA, AdCom, label expansion, or biosimilar milestones.

### Mode: exclusivity-scan

**Objective**: Orange Book and 180-day exclusivity windows as the launch-timing lens.
  • SKILL.md 8 KB 
    ---
name: fda-catalyst-medicines
description: "CDER-track catalyst analysis for medicines: PDUFA target dates, AdCom votes, sNDA/sBLA label expansions, biosimilar interchangeability and 180-day exclusivity, Orange Book state, and CRL remediation timelines — enumerated, verified, and sized per event for any biotech/pharma ticker or watchlist."
sectors: [med.medicines_biotech, med.medical_devices]
multi_ticker_semantics: basket_v1_1
temporal_scope:
  default_quarters: 4
  max_quarters: 8
  description: "Forward catalyst window default 4 quarters; up to 8 for long-horizon exclusivity and remediation mapping."
allowed_tools:
  - get_upcoming_pdufa
  - get_pdufa_decision
  - search_adcom_meetings
  - get_adcom_meeting
  - search_fda_approvals
  - get_fda_approval
  - search_companies
  - get_company_profile
  - search_documents
  - search_sec_filings
  - list_sources
  - read_source_outline
  - read_source_pages
  - search_earnings_calendar
  - list_upcoming_earnings
  - search_investment_cases
  - get_investment_case
  - search_investment_strategies
  - get_investment_strategy
  - search_by_analogue
  - search_knowledge_entries
  - get_knowledge_entry
retrieval_scope: unstructured_document_search
min_tool_diversity: 3
parameter_free: false
---

> Methodology inspired by publicly taught biotech catalyst frameworks; all text is an original paraphrase.

## Defaults

| Parameter | Default Value | Rationale |
|-----------|---------------|-----------|
| forward_window_quarters | 4 | Standard catalyst window; extend to 8 on request |
| include_superseded | false | Active-only events by default; supersede chains on request |
| exclusivity_tracking | true | Orange Book and 180-day exclusivity state attached to launch-relevant events |
| holiday_labeling | true | Holiday-shifted weeks flagged on every calendar row |
| horizon_days | 180 | Default for get_upcoming_pdufa horizon |

## Preflight

Run canonical pre-flight per `contracts/preflight.md`. Propagate X-Agentii-Trace per `contracts/x-agentii-trace-header.md`. Confirm ticker resolution via `search_companies` before catalyst queries.

## Triggers

- "When is the PDUFA date for [drug/ticker]?"
- "What AdCom meetings are coming up for [ticker]?"
- "Has [drug]'s sNDA/sBLA label expansion been approved?"
- "Which biosimilars have interchangeability designation, and when does 180-day exclusivity run?"
- "What is [drug]'s Orange Book patent and exclusivity state?"
- "How is [ticker]'s CRL remediation timeline shaping up?"
- "Build a PDUFA/AdCom calendar for my pharma watchlist."
- "Evaluate the approval odds for [drug] ahead of its AdCom."
- "What label expansions are pending for [ticker] this year?"
- "Which medicine decisions land this quarter?"
- "How do biosimilar launches erode the reference product's share?"
- "Which catalysts overlap with [ticker]'s earnings date?"

## Production Grounding

- CDER mechanics: NDA/BLA review tracks, PDUFA target dates, priority review, breakthrough designation, accelerated approval, CRL deficiency classes and the remediation reset, AdCom vote patterns.
- Label expansions (sNDA/sBLA) are the commercial catalysts beyond first approval; Orange Book patent and exclusivity state sets the generic or biosimilar entry window.
- Biosimilar timeline note: interchangeability plus 180-day exclusivity for the first interchangeable delays competing entry — and approval is not launch; commercial timing follows exclusivity expiry and patent-settlement terms.
- Holiday-week labeling discipline: comps across holiday-shifted weeks are noisy; every calendar row carries its caveat, and holiday weeks are labeled explicitly.
- Apply AdCom-style scrutiny axes when framing outcome odds; never fabricate dates, votes, or outcomes — annotate coverage gaps instead (per `references/knowledge-frameworks.md`).

## Data Source Priority

1. Structured catalyst data: `get_upcoming_pdufa` / `get_pdufa_decision` (pipeline.fda_calendar_event).
2. AdCom and approval history: `search_adcom_meetings` / `get_adcom_meeting`; `search_fda_approvals` / `get_fda_approval`.
3. Company and filing context: `get_company_profile`, `search_documents`, `search_sec_filings`; briefing docs via `list_sources(source_type=adcom_briefing)` + `read_source_outline`/`read_source_pages` with meeting slugs.
4. Historical grounding: `search_investment_cases` (event_type=adcom_vote/pdufa_decision/crl/approval), `search_by_analogue`, `search_investment_strategies` (sectors=med).
5. Earnings overlap: `search_earnings_calendar` / `list_upcoming_earnings`.

## Methodology

### Retrieval Scope
unstructured_document_search

### Retrieval Strategy
1. Resolve ticker(s) via `search_companies`; note primary drug/application names.
2. Pull active PDUFA events (`get_upcoming_pdufa`, horizon_days=default); layer AdCom meetings and earnings dates.
3. Per event: decision history (`get_pdufa_decision` by drug/application), approval record (`get_fda_approval`), label and Orange Book state.
4. For AdCom events, retrieve briefing documents via `list_sources` + `read_source_outline`/`read_source_pages` using meeting slugs; apply scrutiny axes.
5. Ground the play in knowledge: `search_investment_cases` / `search_by_analogue` with med filters; cite /v/ records.

### Temporal Scope
See frontmatter temporal_scope block. Exclusivity windows may require looking back up to 8 quarters when requested.

### Tool Allowlist
See frontmatter allowed_tools.

### Protocol
1. Ticker resolution
2. Catalyst enumeration (PDUFA / AdCom / label expansion / exclusivity events)
3. Per-event outcome framing (scrutiny axes + decision history)
4. Historical analogue retrieval
5. Calendar synthesis + exclusivity and risk flags

## Modes

- **Watchlist** (default, multi-ticker): one dated calendar with per-ticker sections, sorted by date.
- **Single ticker deep-dive**: full event timeline, per-event probability framing, label and exclusivity state.
- **Event type**: restrict to PDUFA / AdCom / label expansion / biosimilar milestones on request.
- **Exclusivity scan**: Orange Book and 180-day windows as the launch-timing lens.

## Tool Fallbacks

| Failure | Fallback |
|---------|----------|
| get_upcoming_pdufa empty | Search filings (`search_documents` keyword PDUFA) + `search_sec_filings` 8-Ks; annotate coverage_gap |
| AdCom briefing path 404 | `search_documents` with source_institution filter; degrade to calendar metadata |
| Knowledge tools empty | Proceed with structured data only; annotate knowledge coverage_gap |
| Orange Book state unknown | Flag exclusivity window unavailable; never infer expiry dates |

## Output File

`{ticker}/{YYYY-MM-DD_HHMM}_fda-catalyst-medicines_{affix}.md` (watchlist: `watchlist/{YYYY-MM-DD_HHMM}_fda-catalyst-medicines-calendar_{affix}.md`)

## Output Structure

1. **Executive Summary** — highest-impact CDER-track catalysts in the window, 2-3 sentences
2. **Catalyst Calendar** — dated table: date, ticker, event type, drug, application, holiday-week flag, expected-impact framing
3. **Per-Event Analysis** — scrutiny-axes assessment (safety/statistics/subgroups/benefit-risk) + decision history
4. **Label & Exclusivity State** — sNDA/sBLA status, Orange Book state, 180-day windows, biosimilar entry timing
5. **Historical Analogues** — matched cases with /v/ citations and quantified outcomes
6. **Risk Assessment & Coverage Gaps** — binary-risk sizing, overlap clusters, unverified or missing data

## Error Handling

| Error | Fallback |
|-------|----------|
| No PDUFA rows | Fall back to earnings + AdCom + label events; annotate `coverage_gap` — never fabricate dates |
| Superseded dates | Active-only by default; expose supersede chain via `include_superseded=true` |
| Ticker not in med universe | Resolve via CIK/drug-universe match; surface the classification gap |

## Memory Load

See `contracts/memory-load.md`.

## Snapshot

See `contracts/snapshot-synthesis.md`.

## Final Summary (TUI)

Include ### Key Citations block with 0-10 clickable /v/ URLs.

## References

- `contracts/citation-and-memory.md`
- `contracts/output-frontmatter-schema.md`
- `contracts/memory-load.md`
- `contracts/snapshot-synthesis.md`
- `contracts/preflight.md`
- `references/knowledge-frameworks.md`

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