{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-21-017696","form_type":"8-K","ticker":"PTIX","cik":"0001022899","company_name":"Protagenic Therapeutics, Inc.new","filed_at":"2021-07-26T23:59:59+00:00","discovered_at":"2026-05-14T18:04:16.887597+00:00","generated_at":"2026-06-30T02:26:36.898966+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Protagenic Therapeutics delays PT00114 clinical trial start to Q4 2021 after FDA request","bullets":["FDA requested ready-to-inject clinical vials instead of local formulation; company refiling IND.","Patient enrollment now expected to begin in Q4 2021 (previously earlier timeline).","Company states implementing FDA guidance adds benefit of controlling final drug product formulation.","Press release dated July 23, 2021; IND filed June 29, 2021."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-21-017696","json":"https://secwatch.observer/filing/0001493152-21-017696.json","markdown":"https://secwatch.observer/filing/0001493152-21-017696.md","text":"https://secwatch.observer/filing/0001493152-21-017696.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1022899/000149315221017696/0001493152-21-017696-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1022899/000149315221017696/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-30T02:26:36.898966+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"}