secwatch.observer — SEC 8-K summary
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Issuer:     Grace Therapeutics, Inc. (GRCE)
CIK:        0001444192
Form:       8-K
Filed at:   2023-04-05T23:59:59+00:00
Accession:  0000950170-23-011938
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 5.02, 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Acasti appoints Prashant Kohli as CEO; FDA allows Phase 3 safety study for GTX-104 to proceed
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- Prashant Kohli appointed CEO effective April 4, 2023, succeeding Jan D'Alvise who mutually agreed to depart.
- FDA Type C meeting response: concurred with 505(b)(2) pathway for GTX-104; Phase 3 safety study can proceed pending final protocol approval.
- Phase 3 trial: 1:1 randomized vs oral nimodipine in aSAH patients at 25-30 US sites; primary endpoint is safety (hypotension adverse events).
- First patient enrollment expected in H2 2023; if primary endpoint met, NDA filing under 505(b)(2) expected to follow.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1444192/000095017023011938/0000950170-23-011938-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1444192/000095017023011938/acst-20230404.htm
  HTML page:      https://secwatch.observer/filing/0000950170-23-011938

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