Fda Catalyst Analysis

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

Defaults

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

• "What FDA catalysts are coming up for [ticker]?"
• "When is the PDUFA date for [drug/ticker]?"
• "Build a catalyst calendar for my biotech watchlist."
• "What AdCom meetings are scheduled for [ticker]?"
• "How does the market typically react to [approval/CRL/AdCom vote]?"
• "What are the binary events for [ticker] over the next 6 months?"
• "Which med names have FDA decisions this quarter?"
• "Evaluate the approval odds for [drug] ahead of its PDUFA."
• "What happened the last time a similar drug went to AdCom?"
• "List upcoming device decisions (PMA/De Novo/510(k)) for [ticker]."
• "Which catalysts overlap with [ticker]'s earnings date?"
• "Recap the decision history for [application/drug]."

Production Grounding

• FDA decisions (approve/CRL/withdraw) are the strongest price catalysts in med.medicines_biotech; AdCom votes often pre-move the stock by days.
• Regulatory mechanics: PDUFA target dates, priority review, breakthrough designation, accelerated approval, CRL remediation timelines, AdCom vote patterns (approve/reject/deferral/conditional), post-marketing requirements.
• AdCom-style scrutiny axes to apply when framing outcome odds: safety signals, statistical adequacy, subgroup analyses, missing data, endpoint appropriateness, benefit-risk reasoning (per references/knowledge-frameworks.md).
• Devices: PMA / De Novo / 510(k) decisions carry similar binary-event dynamics (get_device_decision).
• Never fabricate dates, votes, or outcomes. When a tool returns nothing, annotate the coverage gap.

Data Source Priority