{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-25-102930","form_type":"8-K","ticker":"NTRB","cik":"0001676047","company_name":"NutriBand Inc.","filed_at":"2025-10-28T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.119506+00:00","generated_at":"2026-05-17T01:57:02.467819+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Nutriband receives FDA feedback on AVERSA FENTANYL CMC plans; regulatory pathway confirmed as 505(b)(2)","bullets":["FDA meeting held September 18, 2025; final minutes received; feedback on CMC, registration batch, and stability plans.","FDA confirmed 505(b)(2) NDA path and provided guidance on reference drug bridging strategy.","Company plans to file IND to support a Human Abuse Potential clinical study for the abuse-deterrent fentanyl patch.","Partner Kindeva to develop AVERSA FENTANYL combining Nutriband's AVERSA technology with Kindeva's FDA-approved fentanyl patch.","Peak annual US sales potential estimated at $80M to $200M per market analysis report."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-25-102930","json":"https://secwatch.observer/filing/0001213900-25-102930.json","markdown":"https://secwatch.observer/filing/0001213900-25-102930.md","text":"https://secwatch.observer/filing/0001213900-25-102930.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1676047/000121390025102930/0001213900-25-102930-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1676047/000121390025102930/ea0262795-8k_nutriband.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T01:57:02.467819+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}