secwatch.observer — SEC 8-K summary
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Issuer:     Protagenic Therapeutics, Inc.new (PTIX)
CIK:        0001022899
Form:       8-K
Filed at:   2021-07-26T23:59:59+00:00
Accession:  0001493152-21-017696
Event type: regulatory
Sentiment:  negative
Materiality: 0.60
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Protagenic Therapeutics delays PT00114 clinical trial start to Q4 2021 after FDA request
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- FDA requested ready-to-inject clinical vials instead of local formulation; company refiling IND.
- Patient enrollment now expected to begin in Q4 2021 (previously earlier timeline).
- Company states implementing FDA guidance adds benefit of controlling final drug product formulation.
- Press release dated July 23, 2021; IND filed June 29, 2021.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1022899/000149315221017696/0001493152-21-017696-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1022899/000149315221017696/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-21-017696

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