ODIN Track Record
Verified prediction accuracy with cryptographic proof. 52outcomes since Aug 2025. SHA-256 hash immutable ledger.
96.2% overall accuracy • 12 correctly called CRLs • 16/16 in 2026 • Full outcome audit trail since August 1, 2025
Latest Verified Wins (Feb 2026)
What Is ODIN?
ODIN is a proprietary machine learning system that predicts the outcome of FDA biotech decisions (approvals, rejections, CRL/Complete Response Letters) before they are announced. ODIN assigns each upcoming PDUFA event a confidence tier (TIER_1 through TIER_4).
Unlike sentiment analysis or social media followers, ODIN is trained on:
- Historical FDA approval rates by indication, company, trial design
- Clinical trial data: enrollment, primary endpoints, competitor landscape
- Stock price momentum and technical structure (runup window, IV dynamics)
- Options market pricing (implied probability of approval)
- CEWS (Catalyst Early Warning System): insider trading, C-suite selling patterns
The system's output is a tier (TIER_1 highest confidence, TIER_4 lowest) that has been validated across 53 verified outcomes since August 2025 with a 96.2% accuracy rate.
Overall Track Record Summary (Since August 1, 2025)
Verified Outcomes
Overall Accuracy (51/53)
CRLs Correctly Called
Perfect in 2026
Results by Tier Classification (Since Aug 1, 2025)
| ODIN Tier | Correct Predictions | Accuracy % | Description |
|---|---|---|---|
| TIER_1 (High Confidence) | 26 / 27 | 96.3% | Strong approvals. 1 miss: SNY Tolebrutinib (Hy's Law) |
| TIER_2 (Good Confidence) | 9 / 10 | 90.0% | Includes CAPR +534%, MIST +130%. 1 miss: FBIO original CRL |
| TIER_3 (Mixed/Trap Zone) | 4 / 4 | 100% | 3 CRLs correctly avoided + 1 approval (VNDA Tradipitant) |
| TIER_4 (CRL-Likely) | 11 / 11 | 100% | Perfect CRL/delay detection. Every TIER_4 call correct. |
| CEWS Override | 1 / 1 | 100% | AQST insider selling override saved -40% loss |
Data: Aug 2025 - Feb 2026. Accuracy = correct prediction of approve/reject/CRL/delay. Only 2 misses total across 52outcomes.
Correctly Called CRLs & Delays (13/13 = 100%)
ODIN doesn't just predict approvals — it identifies CRLs and delays BEFORE they happen. Every CRL or delay correctly flagged is money saved. Here are 13 correctly called negative outcomes, each with losses avoided:
| Ticker | Drug | Date | ODIN Tier | Outcome | Loss Avoided |
|---|---|---|---|---|---|
| IRON | Bitopertin (EPP) | Feb 13, 2026 | TIER_4 (39.4%) | CRL | -52% |
| RGNX | RGX-121 (Hunter Syndrome) | Feb 7, 2026 | TIER_4 (45%) | CRL | -21% |
| PHAR | Leniolisib (Joenja pediatric) | Feb 1, 2026 | TIER_3 (58%) | CRL | -28% |
| TVTX | Filspari (Sparsentan) FSGS | Jan 13, 2026 | TIER_4 (42%) | DELAYED | -33% |
| AQST | Anaphylm (epinephrine film) | Jan 9, 2026 | CEWS OVERRIDE | CRL | -40% |
| ATRA | Tabelecleucel (EBV+ PTLD) | Jan 9, 2026 | TIER_4 (28%) | CRL | -22% |
| OTLK | ONS-5010 Lytenava (3rd CRL) | Dec 31, 2025 | TIER_4 (5%) | CRL | -68% |
| CORT | Relacorilant (Cushing's) | Dec 31, 2025 | TIER_3 TRAP (58%) | CRL | -41% |
| BHVN | Troriluzole (SCA) | Nov 4, 2025 | TIER_4 (38%) | CRL | -32% |
| RGNX | RGX-121 (Nov delay) | Nov 9, 2025 | TIER_4 (45%) | DELAYED | -18% |
| SRRK | Nomlabofusp (Friedreich's Ataxia) | Sep 28, 2025 | TIER_4 (42%) | CRL | -38% |
| PTCT | Vatiquinone (Friedreich Ataxia) | Aug 19, 2025 | TIER_3 (31%) | CRL | -61% |
Total losses avoided: -525% combined. ODIN's CRL detection is as valuable as its approval predictions.
2026 Predictions: 16/16 Perfect Record
Every ODIN prediction in 2026 has been correct — 10 approvals (incl. ASND YUVIWEL), 6 CRLs, 1 delay, 1 runup trade. Zero misses.
| Ticker | Drug / Program | Date | ODIN Tier | Outcome | Stock Move |
|---|---|---|---|---|---|
| REGN | Dupixent (AFRS) | Feb 24 | TIER_1 | APPROVED | +7.3% |
| VNDA | Bysanti (milsaperidone) | Feb 20 | TIER_1 | APPROVED | +44% |
| ETON | ET-600 (Desmopressin) | Feb 25 | TIER_2 | APPROVED | +14.7% |
| RCKT | RP-A501 (Danon Disease) | Feb 20 | TIER_4 | RUNUP WIN | +20% |
| IRON | Bitopertin (EPP) | Feb 13 | TIER_4 | CRL | -52% avoided |
| ASND | YUVIWEL (navepegritide) | Feb 27 | TIER_1 | APPROVED | +6% |
| ASND | TransCon hGH Weekly | Feb 7 | TIER_1 | APPROVED | +19% |
| RGNX | RGX-121 (Hunter Syndrome) | Feb 7 | TIER_4 | CRL | -21% avoided |
| PHAR | Leniolisib (APDS pediatric) | Feb 1 | TIER_3 | CRL | -28% avoided |
| JNJ | Darzalex Faspro D-VRd | Jan 27 | TIER_1 | APPROVED | +2% |
| AZN | Tezspire (asthma expansion) | Jan 25 | TIER_1 | APPROVED | +8% |
| NVO | Oral Semaglutide (Wegovy) | Jan 20 | TIER_1 | POSITIVE | +13% |
| FBIO | ZYCUBO (Menkes resub) | Jan 13 | TIER_1 | APPROVED | +22% |
| TVTX | Filspari (FSGS) | Jan 13 | TIER_4 | DELAYED | -33% avoided |
| SNY | Cerezyme (GD3 expansion) | Jan 12 | TIER_1 | APPROVED | +1% |
| AQST | Anaphylm (CEWS override) | Jan 9 | CEWS | CRL | -40% avoided |
| ATRA | Tabelecleucel (EBV+ PTLD) | Jan 9 | TIER_4 | CRL | -22% avoided |
| SNY | Cablivi (pediatric aTTP) | Jan 5 | TIER_1 | APPROVED | +2% |
SHA-256 Hash Verification
To prevent hindsight bias and false claims, every ODIN prediction is locked with a SHA-256 cryptographic hash BEFORE the FDA announcement. This immutable ledger proves:
- We made the prediction on date X (no retroactive changes)
- The prediction was TIER_1 / TIER_2 / etc (no doctoring after the fact)
- The actual outcome (approve/reject/CRL) is documented with timestamp
Latest Hash Ledger Entry (ASND YUVIWEL — Feb 27, 2026):
Prediction: 2026-02-12T23:44:55Z | Git: 300f86b | 15 days before approval
Ticker: ASND | Drug: Navepegritide (YUVIWEL) | ODIN Tier: TIER_1 (88.9%)
SHA-256: 0d39685f6f665df18274d71df5875707b58ae5f939a382414f7fc5d49c8dd4b5
Core Hash: 57e1c8a67ea721e6c5a6e7cda7f1dbdcf71a26affbd88d45f0b41f183d53eb6a
Outcome: APPROVED (Accelerated, 1 day early) | Move: +6% | Prior Chain: 2f75e484...
PREDICTION VERIFIED ✓ — 16/16 in 2026
Every verified outcome on this page is linked to its pre-decision hash. You can independently verify by checking the GitHub commit timestamp at github.com/rockyshoals-lgtm/pdufa-bio/commit/300f86b.
Notable Verified Wins (Since Aug 2025)
| Ticker | Drug / Program | ODIN Score | Outcome | Stock Move |
|---|---|---|---|---|
| CAPR | Deramiocel (HOPE-3) — DMD Cardiomyopathy | TIER_2 (72.5%) | POSITIVE (BEAT) | +534% |
| MIST | Etripamil (CARDAMYST) — PSVT | TIER_1 (82.5%) | APPROVED | +130% |
| TOVX | VCN-01 — Pancreatic Cancer | TIER_2 (67.5%) | POSITIVE | +91% |
| OMER | Narsoplimab (YARTEMLEA) — TMA | TIER_2 (62%) | APPROVED | +76% |
| SNDX | Revumenib (REVUFORJ) — AML | TIER_1 (87.5%) | APPROVED | +51% |
| VNDA | Bysanti (milsaperidone) — Schizophrenia | TIER_1 (89.7%) | APPROVED | +44% |
| VNDA | Tradipitant (NEREUS) — Motion Sickness | TIER_3 (55%) | APPROVED | +42% |
Stock moves are T+5 closing prices post-announcement. These are verified outcomes from the hash ledger since August 2025.
Frequently Asked Questions
How does ODIN predict FDA outcomes?
ODIN is trained on 2,200+ historical FDA events combined with 21 scoring signals. It analyzes: historical approval rates by indication/company, clinical trial design and endpoints, regulatory designations (BTD, Orphan, Priority Review), manufacturing risk profiles (CMO database), and real-time stock/options market pricing. The CEWS (Catalyst Early Warning System) adds insider trading detection with 86-day average lead time on CRLs.
How does ODIN predict CRLs so accurately?
ODIN's CRL detection combines manufacturing risk scoring (Svartalfheim CMO Oracle), therapeutic area risk adjustments (ophthalmology, pain, nephrology are high-risk), clinical trial design analysis (single-arm studies, external controls), and CEWS insider selling cluster detection. TIER_4 calls have a 100% CRL/delay detection rate across 11 events since August 2025.
What does SHA-256 hash verification prove?
The hash proves we made a specific prediction on a specific date BEFORE the FDA announced. It prevents the classic hindsight bias where someone claims they "knew" an approval would happen after it already did. Our track record is immutable: if the prediction hash doesn't match the announcement outcome, it's verifiable proof of error.
Why start tracking from August 1, 2025?
August 1, 2025 represents when ODIN v2.1 (current model) was deployed with improved signal weights and validation methodology. The 96.2% overall accuracy and 100% TIER_4 CRL detection rate reflect this refined system's predictive power across 53 verified outcomes.