“ODIN called VNDA TIER_1 three weeks before approval. I entered at $4.80, sold at $6.91. That one trade paid for 9 years of Pro.”

— Retail trader · r/pennystocks

“The options flow data is what sets this apart. Seeing whale positioning shift 10 days before PDUFA gave me conviction to size up.”

— Active biotech trader · StockTwits

“We integrated the Elite API into our event-driven quant strategy. The ODIN scores provide a measurable alpha signal on PDUFA events.”

— Quantitative analyst · Institutional subscriber

What is ODIN and how does it work?

ODIN (Outcome Determination Intelligence Network) is a machine-learning model trained on 2,210+ historical FDA PDUFA outcomes. It analyzes 45 featureed signals—including clinical efficacy, safety profiles, regulatory designations, sponsor track record, and competitive landscape—to estimate approval probability for upcoming drug decisions. The model assigns each PDUFA catalyst to one of four tiers: TIER_1 (85%+ approval), TIER_2 (65-85%), TIER_3 (40-65%), and TIER_4 (below 40%). Pro and Elite subscribers receive exact probability scores; Free users see only tier assignments.

Can I cancel my subscription anytime?

Yes. Pro and Elite subscriptions are month-to-month with no long-term commitment. You can cancel at any time before your renewal date. Your subscription will remain active through the end of the current billing period. We also offer a 14-day money-back guarantee if you're not satisfied with your subscription.

What data do you export and in what formats?

Pro subscribers can export catalyst data in CSV format, including ODIN scores, approval probabilities, dates, and therapeutic area classifications. Elite subscribers get unlimited JSON/CSV exports, historical backtest data, and full API access with webhooks for real-time event notifications. All data is updated daily as FDA accepts new applications and assigns PDUFA dates.

How accurate is ODIN?

ODIN achieves 96.2% all-time accuracy across 51 verified outcomes (as of February 2026), with 0.9193 AUC walk-forward testing. In February 2026 alone, ODIN correctly predicted all three PDUFA outcomes: ETON (approved), REGN (approved), and VNDA (approved). All predictions are SHA-256 hashed before the PDUFA date for independent verification. Review our detailed track record at /odin-track-record. Note that past performance does not guarantee future results.

Why pay when PDUFA dates are free elsewhere?

PDUFA dates are free everywhere — including here. Pro gives you what nobody else has: AI probability scores from a model that called VNDA +44%, EXEL +38%, and achieved 96.2% all-time accuracy. The dates are the commodity; the ODIN score is the edge. One correct TIER_1 call on a $5K position averages +$2,200 in gains — paying for over 9 years of Pro.

How is PDUFA.BIO different from BioPharmCatalyst or MarketBeat?

BioPharmCatalyst and MarketBeat provide PDUFA calendars — but no AI scoring, no approval probability predictions, and no options flow analysis. PDUFA.BIO is the only platform combining machine-learning approval probability (ODIN), real-time options flow intelligence (put/call ratios, whale bias, unusual activity detection), historical runup backtesting, and SHA-256 verified predictions. The free tier alone matches what competitors charge for.

What are ODIN revenue tiers (R1-R4)?

ODIN revenue tiers estimate the commercial impact of drug approval on the sponsoring company stock. R1 (blockbuster, $1B+ peak sales) typically produces 25-80% post-approval gains. R2 (significant, $500M-$1B) averages 15-40% gains. R3 (moderate, $100M-$500M) averages 8-20% gains. R4 (niche, under $100M) averages 3-12% gains. Elite subscribers receive revenue tier scoring with position multiplier suggestions for catalyst sizing.

Do you provide investment or trading advice?

No. PDUFA.BIO provides data, statistical analysis, and machine-learning predictions for educational and informational purposes. ODIN scores represent probability estimates based on historical patterns, not trading recommendations. Always consult a licensed financial advisor before making investment decisions. See our full disclaimer at /disclaimer.

How do email alerts work?

Pro and Elite subscribers receive automated email alerts at T-25, T-14, T-7, and T-5 days before each PDUFA date. Alerts include the ODIN score, tier assignment, recent options flow data, and a brief catalyst summary. Elite subscribers can customize alert timing and add webhook integrations for automated trading systems.

What is the ODIN options flow intelligence?

ODIN options flow tracks put/call ratios, unusual options activity (UOA), institutional whale positioning, and implied volatility changes around PDUFA dates. It calculates an Options Pressure score (0-100), Whale Bias (-100 to +100), and Vol Shock indicator. This data helps identify when smart money is positioning ahead of FDA decisions. Pro users see summary signals; Elite users get full strike-level chain data.

Can I use the API to build my own tools?

Yes. Pro subscribers get basic API access (100 requests/day) for pulling ODIN scores, PDUFA dates, and catalyst data in JSON format. Elite subscribers get full API access (unlimited requests), webhook event notifications, and historical backtest endpoints. API documentation is available at /api-access after subscribing.

What is SHA-256 prediction verification?

Before each PDUFA date, ODIN publishes a SHA-256 cryptographic hash of its prediction. After the FDA decision, the original prediction text is revealed and anyone can verify it matches the pre-published hash. This proves predictions were made before outcomes were known — no hindsight bias. All hashes are recorded on our data provenance page at /data-provenance.

How often is data updated?

PDUFA calendar data is updated daily as the FDA publishes new target action dates. ODIN scores are recalculated when material information changes (new clinical data, advisory committee votes, manufacturing inspections). Options flow data updates every 5 minutes during market hours. Historical backtest data is refreshed quarterly.

Is there a student or academic discount?

Yes. We offer 50% off Pro for verified students and academic researchers. Contact support with your .edu email address for the discount code. Academic institutions can also inquire about bulk licensing for classroom use.

What payment methods do you accept?

We accept all major credit and debit cards (Visa, Mastercard, American Express, Discover) through Stripe. Annual plans are also available at a 17% discount. All transactions are processed securely and we never store your full card details.