secwatch.observer — SEC 8-K summary
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Issuer:     Anebulo Pharmaceuticals, Inc. (ANEB)
CIK:        0001815974
Form:       8-K
Filed at:   2022-01-03T23:59:59+00:00
Accession:  0001493152-22-000100
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Anebulo doses first patient in Phase 2 study of ANEB-001 for acute cannabinoid intoxication; expects topline in 1H 2022
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- First patient dosed in Phase 2 proof-of-concept study evaluating ANEB-001 for acute cannabinoid intoxication.
- Part A will enroll 60 patients randomized 1:1:1 to 50mg, 100mg ANEB-001 or placebo, all receiving 10.5mg THC challenge.
- Initial topline results from Part A expected in first half of 2022.
- FDA pre-IND meeting provided guidance; Anebulo expects to submit IND in Q1 2022.
- FDA accepted a THC challenge model for efficacy; company plans MIDD paired-meeting request.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1815974/000149315222000100/0001493152-22-000100-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1815974/000149315222000100/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-22-000100

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