Institutional-Grade PDUFA Intelligence

Trade biotech binary events with
precision, not prayer.

Submarine Catalyst scores every upcoming FDA decision using a 7-factor evidence model — indication-specific approval rates, AdCom vote parsing, SEC filing signals, and convexity analysis. Built by a trader who needed it, not a data vendor who guessed.

Start Subscription — $79/mo Cancel anytime  ·  No trial required
ELITE SCANNER v13.0 — LIVE OUTPUT
══════════════════════════════════════════════════
RCKT Final: 84.2/100 🚀 ELITE
PoA: 91.0% [HIGH ✅] | Convexity: 78.4/100
Indication: Rare/Orphan (Gene Therapy)
──────────────────────────────────────────────────
🚨 PRIOR CRL — CMC-only, not efficacy
✅ ADCOM: Unanimous 10-0 → ~99% approval
📊 Convexity Breakdown:
Proximity(13d): 18/25 Price Dep: 16/20
Short Squeeze: 15.1/20 Liquidity: 8/10
📅 PDUFA: 2025-03-28 (13d) | PoA: 91.0%
LAD-I gene therapy | Short: 14.3%
══════════════════════════════════════════════════
The Method

Not a screener. An evidence model.

Every score is a weighted synthesis of seven independent signal layers — not one metric dressed up as many.

01
Calendar Ingestion

Pulls the live PDUFA calendar daily. Every upcoming FDA decision date — new drugs, label expansions, resubmissions — gets queued for scoring automatically.

02
PoA Computation

Blends indication-specific base rates (Hay 2014, Wong 2019) with review pathway type, AdCom vote parsing, and SEC 8-K filing language signals to produce a calibrated approval probability.

03
Convexity Scoring

Measures asymmetry, not just approval odds. Proximity to PDUFA, price depression from 52-week high, short interest, historical volatility, market cap tier, and liquidity combine into a single convexity number.

04
Final Score + Grade

PoA and Convexity are blended into a 0–100 final score using self-calibrating weights that update as actual PDUFA outcomes accumulate in the log. ELITE / STRONG / WATCH / WEAK tiers surface the best setups fast.

Signal Architecture

Seven layers, one number.

Each signal is sourced, weighted, and documented. No black boxes. You can audit every modifier on every ticker.

🧬
Indication Classifier
Maps drug description to 16 therapeutic areas. Applies published FDA phase-3→approval rates per indication. Oncology: 85.5% · Rare/Orphan: 86.2% · CNS: 49%.
Hay 2014 · Wong 2019
📋
Review Pathway
Breakthrough (90%), Priority NME (81%), Accelerated (72%), Resubmission (65%). Blended 50/50 with indication rate to avoid over-reliance on either signal.
FDA PDUFA reports
🗳️
AdCom Vote Parser
Extracts numerical votes from text (e.g. "8-7", "14-0"). Unanimous → 1.25× multiplier. Close vote ≤2 margin → 0.82×. Negative vote → floor near 0.45×. Source: PMC10329213.
PMC10329213
📁
SEC EDGAR Enrichment
Scans 8-K filings from the last 180 days for FDA communication signals: deficiency letters, manufacturing inspection results, complete response references, breakthrough designations.
SEC EDGAR API
🧪
ClinicalTrials.gov Status
Checks Phase 3 trial status for each drug. Completed trials get a 1.02× boost. Terminated or suspended trials trigger a 0.70× discount. Active enrollment noted.
CT.gov API v2
📐
Convexity Model
6-factor asymmetry score: proximity (25pts), price depression from 52w high (20pts), short squeeze potential (20pts), expected move magnitude via HV (15pts), liquidity (10pts), size tier (10pts).
Proprietary
🎯
Self-Calibrating Weights
After 10+ completed PDUFA outcomes are logged, the PoA/Convexity blend recalibrates automatically based on which factor actually predicted approval in real data.
Outcome log v13
// RCKT — Score Breakdown
Indication base
86%
Review pathway
65%
AdCom (10-0)
×1.25
Prior CRL
×0.58
SEC signals
+3%
Proximity (13d)
18/25
Price depression
16/20
Short squeeze
15/20
FINAL SCORE
PoA 60% · Conv 40%
84.2
Pricing

One tier. Full access.

No freemium limitations. No data delays. No upsells. Full scanner output, updated every scan cycle.

    What you get
  • Full scanner output on every PDUFA event in the calendar
  • Live PoA scores with all 7 signal layers visible
  • Convexity breakdowns on every ticker
  • Risk flags: prior CRLs, extensions, AdCom votes, SEC filings
  • ELITE / STRONG / WATCH / WEAK grading surfaced first
  • Dashboard updated each scan cycle
  • Email alerts when high-score setups enter the window
PRO ACCESS
$ 79 /month

Full scanner · All tickers · All signals

  • Complete PDUFA calendar coverage
  • 7-layer PoA scoring (indication, pathway, AdCom, SEC, CT.gov)
  • Convexity scores + all components
  • Risk flag detection on every ticker
  • Self-calibrating weight updates
  • Performance log with historical outcomes
  • Email alerts for ELITE setups ≤30 days out
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⚠️ Important Submarine Catalyst is a quantitative scoring tool, not investment advice. PDUFA binary events carry substantial risk. A high score reflects favorable evidence — it does not guarantee approval. Position sizing, risk management, and final trade decisions are entirely yours.

This is a tool built for traders who already understand biotech catalyst risk and want a systematic edge in evaluating setups.
Origin

Built in the hours before open.

Submarine Catalyst started as a private tool — a systematic framework for scoring FDA binary events built by someone who needed to trust instruments over intuition. The same discipline that keeps a submarine crew alive in 600 feet of water transfers directly to trading a PDUFA date: no noise, no emotion, no guessing.

Version 13 of the scanner runs seven independent evidence layers derived from published FDA approval rate studies, SEC filing signals, and convexity modeling. It doesn't pick winners — it identifies where the evidence is strongest and where the setup is most asymmetric.

The performance log is built to be filled in after each event. Every outcome updates the model. That's the part most scanners skip.

v13 Scanner Version
7 Signal Layers
16 Indication Categories
86% Rare/Orphan Base Rate