Track Record
Three layers of evidence. Every live PDUFA classification documented against the actual FDA outcome — wins and losses both on the record. A 102-event retrospective backtest running the same PoA engine against 25 months of FDA history. And a $1M portfolio simulation that compounds each classification through time to show what a subscriber mirroring the calls would have experienced.
| Ticker | Drug / Indication | PDUFA Date | PoA | Grade | STN Risk | FDA Outcome | Actual Move | PoA ✓ |
|---|---|---|---|---|---|---|---|---|
| Fetching track record from database… | ||||||||
102-Event Backtest
Every NME approval and CRL the FDA issued between February 2024 and March 2026. Rescored retroactively using the same PoA engine that runs on live events today. Built as a calibration test — not a curve-fit.
classifyIndication, getPathwayRate, parseAdcomMultiplier) are byte-for-byte identical to the production score-events engine. Source: FDA CDER NME 2024 + 2025 lists and Drugs@FDA CRL database.
For each PoA bucket, the share of drugs that actually approved. A calibrated model matches: events scored 80–89% PoA should approve ~85% of the time. The vertical tick marks the bucket midpoint; the bar shows actual approval rate observed.
| Date | Ticker | Drug | Indication Area | Type | PoA | Call | Outcome | ✓ |
|---|---|---|---|---|---|---|---|---|
| Loading 102 events… | ||||||||
Same $1M portfolio simulation applied to the full backtested universe above. Each event sized equally, direction set by scanner_call (APPROVE → long, CRL → short, WATCH → skipped — no capital deployed), compounded chronologically through 25 months of FDA decisions.
| # | Date | Ticker | Dir | Outcome | Return | Position | P&L | Equity |
|---|---|---|---|---|---|---|---|---|
| Loading backtest sequence… | ||||||||
PRIVATE), foreign-exchange (BOT.AX, BSLN, LUMI, HLB), and unfunded (CHINA, SUNPHARMA) tickers are excluded rather than modeled. This shrinks the trade count from all ~92 directional calls to the ~73 that have real post-decision price data, and keeps every P&L figure traceable to actual market activity. It still only validates the PoA layer — the STN, dilution, and convexity filters that would have cut or sized down the worst setups aren't applied here, so in practice a trader using the full scanner would have skipped some of these and the curve would differ. Non-overlapping events and no leverage means IRR collapses to CAGR.
Portfolio IRR
What a subscriber mirroring the live scanner calls would have experienced. $1M starting capital, fixed-percent position sizing, compounded chronologically through every resolved classification. Non-overlapping events, no leverage — so IRR collapses cleanly to CAGR.
$1,000,000. Each resolved trade sized at a fixed percentage of current account equity (toggle below). Trades executed chronologically by PDUFA decision date. WATCH-list classifications (no position taken) are excluded. trade_type determines direction — LONG uses return_pct as-is, SHORT inverts it. Because PDUFA events rarely overlap at the portfolio level, the sequence compounds cleanly and IRR collapses to CAGR: (ending / starting)^(1/years) − 1. No leverage, no options, no overlapping positions, no intra-trade management. Fees and slippage not modeled.
| # | Date | Ticker | Dir | Result | Return | Position | P&L | Equity |
|---|---|---|---|---|---|---|---|---|
| Loading trades… | ||||||||
How We Track Accuracy
Every PDUFA event scored by Submarine Catalyst is logged before the FDA decision date. After the decision, the actual outcome (Approved, CRL, Delayed, Withdrawn) is recorded against our predicted PoA score and grade.
A prediction is marked correct if: the scanner scored PoA ≥ 65% and the drug was approved, OR the scanner scored PoA < 50% and the drug received a CRL/rejection. Delayed events are not counted as wins or losses.
Sell-The-News (STN) Risk Score
Approval ≠ stock move. The scanner includes a Post-Approval Move Score that predicts whether an FDA approval will actually move the stock. This was added after observing that RCKT was approved (PoA correct) but the stock dropped 20% — a textbook sell-the-news event.
The STN Risk score evaluates:
• PoA priced-in factor — Higher PoA = more priced in = less upside on approval
• Application type — sNDA/supplements are incremental, not transformative
• Revenue potential — Small/rare indication vs large market blockbuster
• AdCom unanimity — Unanimous vote = zero surprise value in approval
• Resubmission status — Post-CRL approval was already expected
• Competitive landscape — Crowded market reduces differentiation
• First-in-class / PRV eligible — Unique value drivers that support price
Risk levels: VERY LOW → LOW → MODERATE → ELEVATED → HIGH
The PoA model tells you IF it gets approved. The STN risk tells you if that approval is worth trading.
The Backtest — Why It Exists
A short live track record is a short live track record, and sophisticated biotech investors know it. The retrospective backtest runs the same PoA engine against every FDA NME decision from February 2024 forward — a fixed, auditable universe of 102 events pulled from the FDA CDER NME lists and the Drugs@FDA CRL database.
The scoring code is the same code that runs in production: the three core functions (classifyIndication, getPathwayRate, parseAdcomMultiplier) are duplicated byte-for-byte from the live score-events edge function, with a synced-block comment preventing silent divergence. The backtest can only validate what production actually uses.
This page is updated within 24 hours of every live PDUFA resolution. The backtest is re-run any time production PoA logic changes. No exceptions. No deletions.
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