secwatch.observer — SEC 8-K summary
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Issuer:     AVENUE THERAPEUTICS, INC. (ATXI)
CIK:        0001644963
Form:       8-K
Filed at:   2023-04-17T23:59:59+00:00
Accession:  0001104659-23-046174
Event type: regulatory
Sentiment:  neutral
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Avenue Therapeutics announces FDA agreement on most protocol items for IV Tramadol safety study
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- Received official meeting minutes from FDA Type C meeting on March 9, 2023, for IV Tramadol.
- FDA and Avenue agree on majority of proposed protocol items for opioid-induced respiratory depression study vs IV morphine.
- FDA agrees a successful study could support complete response to second Complete Response Letter for IV Tramadol.
- Company expects to finalize protocol and potentially initiate Phase 3 safety study this year; also planning updates on AJ201 and BAER-101 programs.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1644963/000110465923046174/0001104659-23-046174-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1644963/000110465923046174/tm2312933d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-046174

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer