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`. Include the `X-Agentii-Trace` header on every tool call per `contracts/x-agentii-trace-header.md` — carry the `_run_id` from your first tool result and name yourself (and your parent, if you were spawned). 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." - "...