{"slug":"fda-catalyst-medicines","title":"fda-catalyst-medicines","summary":"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","platform":"Claude","tags":[],"authorName":"LLM Mart","authorSlug":"llm-mart","score":0,"source":"github","price":null,"verified":false,"createdAt":"2026-09-15T18:28:51.693483Z","repo":{"url":"https://github.com/agentii-ai/agentii-investment-intelligence","stars":206,"forks":16,"license":"Apache-2.0","updatedAt":"2026-09-29T07:17:16Z"},"bodyHtml":"<hr>\n<p>name: fda-catalyst-medicines\ndescription: \"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.\"\nsectors: [med.medicines_biotech, med.medical_devices]\nmulti_ticker_semantics: basket_v1_1\ntemporal_scope:\ndefault_quarters: 4\nmax_quarters: 8\ndescription: \"Forward catalyst window default 4 quarters; up to 8 for long-horizon exclusivity and remediation mapping.\"\nallowed_tools:</p>\n<ul>\n<li>get_upcoming_pdufa</li>\n<li>get_pdufa_decision</li>\n<li>search_adcom_meetings</li>\n<li>get_adcom_meeting</li>\n<li>search_fda_approvals</li>\n<li>get_fda_approval</li>\n<li>search_companies</li>\n<li>get_company_profile</li>\n<li>search_documents</li>\n<li>search_sec_filings</li>\n<li>list_sources</li>\n<li>read_source_outline</li>\n<li>read_source_pages</li>\n<li>search_earnings_calendar</li>\n<li>list_upcoming_earnings</li>\n<li>search_investment_cases</li>\n<li>get_investment_case</li>\n<li>search_investment_strategies</li>\n<li>get_investment_strategy</li>\n<li>search_by_analogue</li>\n<li>search_knowledge_entries</li>\n<li>get_knowledge_entry\nretrieval_scope: unstructured_document_search\nmin_tool_diversity: 3\nparameter_free: false</li>\n</ul>\n<hr>\n<blockquote>\n<p>Methodology inspired by publicly taught biotech catalyst frameworks; all text is an original paraphrase.</p>\n</blockquote>\n<h2>Defaults</h2>\n<table>\n<thead>\n<tr>\n<th>Parameter</th>\n<th>Default Value</th>\n<th>Rationale</th>\n</tr>\n</thead>\n<tbody>\n<tr>\n<td>forward_window_quarters</td>\n<td>4</td>\n<td>Standard catalyst window; extend to 8 on request</td>\n</tr>\n<tr>\n<td>include_superseded</td>\n<td>false</td>\n<td>Active-only events by default; supersede chains on request</td>\n</tr>\n<tr>\n<td>exclusivity_tracking</td>\n<td>true</td>\n<td>Orange Book and 180-day exclusivity state attached to launch-relevant events</td>\n</tr>\n<tr>\n<td>holiday_labeling</td>\n<td>true</td>\n<td>Holiday-shifted weeks flagged on every calendar row</td>\n</tr>\n<tr>\n<td>horizon_days</td>\n<td>180</td>\n<td>Default for get_upcoming_pdufa horizon</td>\n</tr>\n</tbody>\n</table>\n<h2>Preflight</h2>\n<p>Run canonical pre-flight per <code>contracts/preflight.md</code>. Propagate X-Agentii-Trace per <code>contracts/x-agentii-trace-header.md</code>. Confirm ticker resolution via <code>search_companies</code> before catalyst queries.</p>\n<h2>Triggers</h2>\n<ul>\n<li>\"When is the PDUFA date for [drug/ticker]?\"</li>\n<li>\"What AdCom meetings are coming up for [ticker]?\"</li>\n<li>\"Has [drug]'s sNDA/sBLA label expansion been approved?\"</li>\n<li>\"Which biosimilars have interchangeability designation, and when does 180-day exclusivity run?\"</li>\n<li>\"What is [drug]'s Orange Book patent and exclusivity state?\"</li>\n<li>\"How is [ticker]'s CRL remediation timeline shaping up?\"</li>\n<li>\"Build a PDUFA/AdCom calendar for my pharma watchlist.\"</li>\n<li>\"Evaluate the approval odds for [drug] ahead of its AdCom.\"</li>\n<li>\"What label expansions are pending for [ticker] this year?\"</li>\n<li>\"Which medicine decisions land this quarter?\"</li>\n<li>\"How do biosimilar launches erode the reference product's share?\"</li>\n<li>\"Which catalysts overlap with [ticker]'s earnings date?\"</li>\n</ul>\n<h2>Production Grounding</h2>\n<ul>\n<li>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.</li>\n<li>Label expansions (sNDA/sBLA) are the commercial catalysts beyond first approval; Orange Book patent and exclusivity state sets the generic or biosimilar entry window.</li>\n<li>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.</li>\n<li>Holiday-week labeling discipline: comps across holiday-shifted weeks are noisy; every calendar row carries its caveat, and holiday weeks are labeled explicitly.</li>\n<li>Apply AdCom-style scrutiny axes when framing outcome odds; never fabricate dates, votes, or outcomes — annotate coverage gaps instead (per <code>references/knowledge-frameworks.md</code>).</li>\n</ul>\n<h2>Data Source Priority</h2>\n<ol>\n<li>Structured catalyst data: <code>get_upcoming_pdufa</code> / <code>get_pdufa_decision</code> (pipeline.fda_calendar_event).</li>\n<li>AdCom and approval history: <code>search_adcom_meetings</code> / <code>get_adcom_meeting</code>; <code>search_fda_approvals</code> / <code>get_fda_approval</code>.</li>\n<li>Company and filing context: <code>get_company_profile</code>, <code>search_documents</code>, <code>search_sec_filings</code>; briefing docs via <code>list_sources(source_type=adcom_briefing)</code> + <code>read_source_outline</code>/<code>read_source_pages</code> with meeting slugs.</li>\n<li>Historical grounding: <code>search_investment_cases</code> (event_type=adcom_vote/pdufa_decision/crl/approval), <code>search_by_analogue</code>, <code>search_investment_strategies</code> (sectors=med).</li>\n<li>Earnings overlap: <code>search_earnings_calendar</code> / <code>list_upcoming_earnings</code>.</li>\n</ol>\n<h2>Methodology</h2>\n<h3>Retrieval Scope</h3>\n<p>unstructured_document_search</p>\n<h3>Retrieval Strategy</h3>\n<ol>\n<li>Resolve ticker(s) via <code>search_companies</code>; note primary drug/application names.</li>\n<li>Pull active PDUFA events (<code>get_upcoming_pdufa</code>, horizon_days=default); layer AdCom meetings and earnings dates.</li>\n<li>Per event: decision history (<code>get_pdufa_decision</code> by drug/application), approval record (<code>get_fda_approval</code>), label and Orange Book state.</li>\n<li>For AdCom events, retrieve briefing documents via <code>list_sources</code> + <code>read_source_outline</code>/<code>read_source_pages</code> using meeting slugs; apply scrutiny axes.</li>\n<li>Ground the play in knowledge: <code>search_investment_cases</code> / <code>search_by_analogue</code> with med filters; cite /v/ records.</li>\n</ol>\n<h3>Temporal Scope</h3>\n<p>See frontmatter temporal_scope block. Exclusivity windows may require looking back up to 8 quarters when requested.</p>\n<h3>Tool Allowlist</h3>\n<p>See frontmatter allowed_tools.</p>\n<h3>Protocol</h3>\n<ol>\n<li>Ticker resolution</li>\n<li>Catalyst enumeration (PDUFA / AdCom / label expansion / exclusivity events)</li>\n<li>Per-event outcome framing (scrutiny axes + decision history)</li>\n<li>Historical analogue retrieval</li>\n<li>Calendar synthesis + exclusivity and risk flags</li>\n</ol>\n<h2>Modes</h2>\n<ul>\n<li><strong>Watchlist</strong> (default, multi-ticker): one dated calendar with per-ticker sections, sorted by date.</li>\n<li><strong>Single ticker deep-dive</strong>: full event timeline, per-event probability framing, label and exclusivity state.</li>\n<li><strong>Event type</strong>: restrict to PDUFA / AdCom / label expansion / biosimilar milestones on request.</li>\n<li><strong>Exclusivity scan</strong>: Orange Book and 180-day windows as the launch-timing lens.</li>\n</ul>\n<h2>Tool Fallbacks</h2>\n<table>\n<thead>\n<tr>\n<th>Failure</th>\n<th>Fallback</th>\n</tr>\n</thead>\n<tbody>\n<tr>\n<td>get_upcoming_pdufa empty</td>\n<td>Search filings (<code>search_documents</code> keyword PDUFA) + <code>search_sec_filings</code> 8-Ks; annotate coverage_gap</td>\n</tr>\n<tr>\n<td>AdCom briefing path 404</td>\n<td><code>search_documents</code> with source_institution filter; degrade to calendar metadata</td>\n</tr>\n<tr>\n<td>Knowledge tools empty</td>\n<td>Proceed with structured data only; annotate knowledge coverage_gap</td>\n</tr>\n<tr>\n<td>Orange Book state unknown</td>\n<td>Flag exclusivity window unavailable; never infer expiry dates</td>\n</tr>\n</tbody>\n</table>\n<h2>Output File</h2>\n<p><code>{ticker}/{YYYY-MM-DD_HHMM}_fda-catalyst-medicines_{affix}.md</code> (watchlist: <code>watchlist/{YYYY-MM-DD_HHMM}_fda-catalyst-medicines-calendar_{affix}.md</code>)</p>\n<h2>Output Structure</h2>\n<ol>\n<li><strong>Executive Summary</strong> — highest-impact CDER-track catalysts in the window, 2-3 sentences</li>\n<li><strong>Catalyst Calendar</strong> — dated table: date, ticker, event type, drug, application, holiday-week flag, expected-impact framing</li>\n<li><strong>Per-Event Analysis</strong> — scrutiny-axes assessment (safety/statistics/subgroups/benefit-risk) + decision history</li>\n<li><strong>Label &amp; Exclusivity State</strong> — sNDA/sBLA status, Orange Book state, 180-day windows, biosimilar entry timing</li>\n<li><strong>Historical Analogues</strong> — matched cases with /v/ citations and quantified outcomes</li>\n<li><strong>Risk Assessment &amp; Coverage Gaps</strong> — binary-risk sizing, overlap clusters, unverified or missing data</li>\n</ol>\n<h2>Error Handling</h2>\n<table>\n<thead>\n<tr>\n<th>Error</th>\n<th>Fallback</th>\n</tr>\n</thead>\n<tbody>\n<tr>\n<td>No PDUFA rows</td>\n<td>Fall back to earnings + AdCom + label events; annotate <code>coverage_gap</code> — never fabricate dates</td>\n</tr>\n<tr>\n<td>Superseded dates</td>\n<td>Active-only by default; expose supersede chain via <code>include_superseded=true</code></td>\n</tr>\n<tr>\n<td>Ticker not in med universe</td>\n<td>Resolve via CIK/drug-universe match; surface the classification gap</td>\n</tr>\n</tbody>\n</table>\n<h2>Memory Load</h2>\n<p>See <code>contracts/memory-load.md</code>.</p>\n<h2>Snapshot</h2>\n<p>See <code>contracts/snapshot-synthesis.md</code>.</p>\n<h2>Final Summary (TUI)</h2>\n<p>Include ### Key Citations block with 0-10 clickable /v/ URLs.</p>\n<h2>References</h2>\n<ul>\n<li><code>contracts/citation-and-memory.md</code></li>\n<li><code>contracts/output-frontmatter-schema.md</code></li>\n<li><code>contracts/memory-load.md</code></li>\n<li><code>contracts/snapshot-synthesis.md</code></li>\n<li><code>contracts/preflight.md</code></li>\n<li><code>references/knowledge-frameworks.md</code></li>\n</ul>\n","files":[{"path":"references/knowledge-frameworks.md","sizeBytes":5218,"isText":true},{"path":"references/modes.md","sizeBytes":604,"isText":true},{"path":"SKILL.md","sizeBytes":8378,"isText":true}],"reviewScore":null,"reviewSummary":null,"trust":{"provenance":"trusted-source-unreviewed","notice":"Community-authored content, reproduced verbatim and not vetted as instructions. 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