secwatch.observer — SEC 8-K summary
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Issuer:     Vivani Medical, Inc. (VANI)
CIK:        0001266806
Form:       8-K
Filed at:   2023-08-29T23:59:59+00:00
Accession:  0001753926-23-001153
Event type: regulatory
Sentiment:  negative
Materiality: 0.75
Item codes: 1.01, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Vivani's NPM-119 trial on clinical hold; submits Complete Response to FDA
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- FDA placed LIBERATE-1 study on clinical hold Aug 11, citing insufficient CMC information to assess human subject risks.
- Vivani submitted Complete Response on Aug 25; FDA has 30 days to respond.
- If hold lifted, Phase 2a trial expected to start Oct 2023, interim results 1H2024, top-line 2H2024.
- If CR inadequate, timeline delayed by ~one quarter.
- Cortigent subsidiary to repay $1.5M and issue $2M promissory note at 5% under amended funding agreement.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1266806/000175392623001153/0001753926-23-001153-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1266806/000175392623001153/g083730_8k.htm
  HTML page:      https://secwatch.observer/filing/0001753926-23-001153

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