fda-catalyst-medicines

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