Important: PDUFA.BIO is not the FDA. ODIN scores are ML model outputs, not financial advice. All investing carries risk. Read full disclaimer →
ODIN is a machine-learning scoring engine purpose-built for one job: quantifying FDA approval probability for upcoming PDUFA catalyst events. It exists because retail biotech investors face the same binary risk events as institutional desks, but without systematic tools to assess them.
Every PDUFA date is a coin flip for most investors. ODIN turns that coin flip into a weighted probability by analyzing 54 distinct signals across regulatory history, manufacturing quality, clinical endpoint strength, therapeutic area risk, and FDA era effects. The current v1108 engine achieves 0.88 AUC on validation and 0.91 AUC on walk-forward testing. The core principle: the RUNUP is the trade — never hold through the binary event.
At its core, ODIN is a 54-weight logistic regression trained on 2,210 historical FDA PDUFA events (713 CRLs, 32.3% base rate) from 2015 through 2026. The current architecture (v1108) uses 33 canonical weights, 15 era/extension weights, and 6 interaction terms, optimized via random perturbation + selection on validation Brier score (0.102 val, 0.088 walk-forward).
For each upcoming catalyst, ODIN starts with a base probability derived from the overall historical approval rate, then adds or subtracts weighted signals based on the specific characteristics of that drug, company, and regulatory context. The raw logit score passes through a sigmoid function to produce a final probability between 0% and 100%.
Catalysts are then assigned to conviction tiers that drive position sizing and risk management. Tier 1 events represent the highest-conviction opportunities. Tier 4 events carry enough red flags that ODIN recommends no position.
ODIN is a statistical tool, not a crystal ball. It quantifies historical patterns — it does not predict the future. FDA decisions are influenced by factors no model can fully capture: advisory committee dynamics, post-submission safety signals, political considerations, and manufacturing inspections that happen behind closed doors.
ODIN does not provide financial advice. Probability scores are statistical estimates based on publicly available historical data. They are not recommendations to buy, sell, or hold any security. Past approval rates do not guarantee future results. Always consult a qualified financial advisor before making investment decisions.
Binary catalyst events can result in extreme price volatility regardless of what any model predicts. Never invest money you cannot afford to lose.
FDA catalyst intelligence powered by the ODIN v1108 scoring engine. Trained on 2,200+ PDUFA decisions & 2,000+ phase readouts (2015–2026).
PDUFA.BIO is the data-driven FDA PDUFA calendar and biotech catalyst calendar built for quantitative investors. Track upcoming PDUFA dates for 2026, FDA drug approval action dates, and biotech earnings dates in a unified, filterable calendar. Learn what a PDUFA date is and how the ODIN AI scoring engine generates FDA approval probability scores. Use the biotech catalyst screener to filter by ticker, therapeutic area, and ODIN tier. Explore the PDUFA runup strategy and verify ODIN's accuracy on the verified track record page. Browse our biotech glossary and catalyst research hub.
DISCLAIMER: PDUFA.BIO is not affiliated with, endorsed by, or connected to the U.S. Food & Drug Administration (FDA) or any government agency. The name "PDUFA" refers to the Prescription Drug User Fee Act and is used descriptively. This site does not provide financial, investment, legal, or medical advice. PDUFA.BIO is not a registered investment advisor, broker-dealer, or financial planner. Probability scores are generated by machine-learning models based on historical data and publicly available information. These scores are statistical estimates, not predictions or guarantees of FDA action or securities performance. Past approval rates do not guarantee future results.
RISK WARNING: Investing in biotechnology and pharmaceutical securities involves substantial risk, including the risk of total loss of capital. Binary catalyst events (such as PDUFA dates) can result in extreme price volatility. You should not invest money you cannot afford to lose. Always consult with a qualified financial advisor before making investment decisions. PDUFA.BIO, its operators, contributors, and affiliates accept no responsibility or liability for any losses arising from use of this site.