{"data":{"available":true,"headline":"FDA PDUFA date predictions: median error 1.0 day(s), 91% within 30 days (n=109 matched decisions, 17 rejection(s)).","date_accuracy":{"decisions_matched":109,"matched_approvals":92,"matched_crls":17,"median_delta_days":1.0,"within_7_days":0.7248,"within_30_days":0.9083},"coverage":{"predictions_total":240,"baseline_decisions_matched":85,"implausible_dropped":0,"unmatched":149,"addressable_caught":34,"decisions_addressable":111,"recall_addressable":0.3063,"crl_decisions":9,"rejections":{"addressable":46,"caught":12,"recall":0.2609,"note":"Coverage of FDA REJECTIONS (Complete Response Letters), reported separately from approvals recall because the two denominators are not comparable: the approvals dataset is complete, while openFDA's CRL corpus is an expanding transparency programme. Scope matches the approvals denominator (NDA/BLA, public sponsor). Date accuracy on the rejections we DID catch is in date_accuracy.matched_crls."}},"windows":{"filing":["2023-01-01","2025-12-31"],"action":["2023-01-01","2026-06-29"]},"additional_rejections":{"count":6,"note":"Rejections (CRLs) captured from a company's own SEC filing — grounded, EDGAR-verifiable — but with no FDA application number to independently date. Counted here for coverage; deliberately EXCLUDED from the headline n and the date-accuracy median above (the disclosure date is not the FDA decision date). Each upgrades into the headline set automatically if the reconcile later recovers a verifiable app# + decision date.","items":[{"drug_name":"CTx-1301 (dexmethylphenidate HCl)","company":"Cingulate Inc.","ticker":"CING","disclosed":"2026-06-02","source_quote":"Cingulate Receives Complete Response Letter from FDA for CTx-1301","filing_url":"https://www.sec.gov/Archives/edgar/data/1862150/000149315226026760/0001493152-26-026760-index.htm"},{"drug_name":"cytisinicline","company":"Achieve Life Sciences, Inc.","ticker":"ACHV","disclosed":"2026-05-12","source_quote":"As a result, Achieve expects to receive a Complete Response Letter from the FDA on or before June 20, 2026, the Prescription Drug User Fee Act goal date.","filing_url":"https://www.sec.gov/Archives/edgar/data/949858/000119312526218175/0001193125-26-218175-index.htm"},{"drug_name":"GTx-104","company":"Grace Therapeutics, Inc.","ticker":"GRCE","disclosed":"2026-04-23","source_quote":"Grace Therapeutics Provides Regulatory Update on New Drug Application for GTx-104 FDA Issued Complete Response Letter","filing_url":"https://www.sec.gov/Archives/edgar/data/1444192/000114036126016324/0001140361-26-016324-index.htm"},{"drug_name":"reproxalap","company":"Aldeyra Therapeutics, Inc.","ticker":"ALDX","disclosed":"2026-03-17","source_quote":"On March 17, 2026, Aldeyra announced that it had received a Complete Response Letter from the FDA (the \"2026 Complete Response Letter\").","filing_url":"https://www.sec.gov/Archives/edgar/data/1341235/000119312526109511/0001193125-26-109511-index.htm"},{"drug_name":"relacorilant","company":"Corcept Therapeutics Incorporated","ticker":"CORT","disclosed":"2025-12-31","source_quote":"today announced that the U.S. Food and Drug Administration (FDA or the Agency) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for relacorilant as a treatment for patients with hypertension secondary to hypercortisolism","filing_url":"https://www.sec.gov/Archives/edgar/data/1088856/000119312525338184/0001193125-25-338184-index.htm"},{"drug_name":"tolebrutinib","company":"Sanofi","ticker":"SNY","disclosed":"2025-12-29","source_quote":"The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the new drug application of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) in adult patients.","filing_url":"https://www.sec.gov/Archives/edgar/data/1121404/000119312525332163/0001193125-25-332163-index.htm"}]},"method":"Predicted PDUFA dates (extracted from SEC 8-K/6-K filings) matched on drug+sponsor against openFDA FDA decisions, bounded to |Δ|≤180d and keyed on the FDA decision.","caveat":"Date accuracy is the defensible headline. Recall is a diagnostic band: the addressable denominator rests on sponsor→public-name matching, which has a real error rate, and some 'unmatched' predictions are openFDA coverage gaps (CBER biologics), not misses. The headline blends the committed 2023–2025 backtest with live decisions resolved since — as fuzzy matches are audited — while recall stays the frozen baseline band — so date_accuracy.decisions_matched (live-blended) can exceed coverage.baseline_decisions_matched (frozen). Rejections (CRLs) are captured from company filings + the openFDA CRL dataset; date_accuracy.matched_crls labels how many entered the median, and coverage.crl_decisions is the total captured — but capture is incomplete, so rejection counts undercount reality.","verify":"Every row in track_record is a resolved FDA decision (never an upcoming prediction). Confirm any date against the FDA's public records (openFDA / Drugs@FDA) using its application_number — the prediction itself came from a public SEC filing. That is what makes this independently auditable rather than a self-reported number.","track_record":[{"sponsor":"Celcuity Inc.","ticker":"CELC","application_number":"NDA219908","predicted_date":"2026-07-17","actual_date":"2026-07-14","error_days":3,"outcome":"approved","had_prior_crl":false,"source":"openfda_drugsfda"},{"sponsor":"Vera Therapeutics, Inc.","ticker":"VERA","application_number":"BLA761486","predicted_date":"2026-07-07","actual_date":"2026-07-07","error_days":0,"outcome":"approved","had_prior_crl":false,"source":"purple_book"},{"sponsor":"Unicycive Therapeutics, 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