secwatch.observer — SEC 8-K summary
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Issuer:     Vivani Medical, Inc. (VANI)
CIK:        0001266806
Form:       8-K
Filed at:   2023-09-18T23:59:59+00:00
Accession:  0001753926-23-001239
Event type: regulatory
Sentiment:  negative
Materiality: 0.70
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Vivani Medical provides update on FDA clinical hold for NPM-119 diabetes implant
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- FDA placed full clinical hold on NPM-119 Phase 2a LIBERATE-1 study on Aug 18, 2023, due to CMC deficiencies.
- Second complete response submitted Sept 15, 2023; FDA has 30 days to respond.
- If hold lifted, trial start in 2023, interim data 1H2024, full top-line 2H2024.
- If response deemed inadequate, Vivani will provide updated guidance.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1266806/000175392623001239/0001753926-23-001239-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1266806/000175392623001239/g083757_8k.htm
  HTML page:      https://secwatch.observer/filing/0001753926-23-001239

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