secwatch.observer — SEC 8-K summary
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Issuer:     Cocrystal Pharma, Inc. (COCP)
CIK:        0001412486
Form:       8-K
Filed at:   2024-03-19T23:59:59+00:00
Accession:  0001493152-24-010426
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Cocrystal Pharma gets FDA Pre-IND feedback on oral CC-42344 for influenza A
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- Received FDA Pre-IND written response to January 2024 submission for oral CC-42344.
- Guidance clarifies regulatory requirements for planned Phase 2b trial design.
- Phase 2a challenge study in UK ongoing; topline results expected H2 2024.
- Preparations underway for inhaled CC-42344 Phase 1 study in Australia.
- Inhaled formulation showed superior lung exposure and favorable safety in preclinical data.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1412486/000149315224010426/0001493152-24-010426-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1412486/000149315224010426/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-010426

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