secwatch.observer — SEC 8-K summary
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Issuer:     DiaMedica Therapeutics Inc. (DMAC)
CIK:        0001401040
Form:       8-K
Filed at:   2022-10-26T23:59:59+00:00
Accession:  0001437749-22-024801
Event type: regulatory
Sentiment:  negative
Materiality: 0.70
Item codes: 2.02, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA maintains clinical hold on DiaMedica's ReMEDy2 stroke trial; cash $36.1M
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- FDA requires additional in-use IV stability study (tubing + pump) to lift clinical hold on Phase 2/3 ReMEDy2 trial.
- Cash, equivalents, and marketable securities were $36.1M as of Sept 30, 2022; Q3 cash burn $2.3M.
- Company will request Type A FDA meeting to confirm study design and gain guidance toward resumption.
- Three transient hypotension cases led to hold; all patients recovered without lasting effects.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1401040/000143774922024801/0001437749-22-024801-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1401040/000143774922024801/dmtp20221026_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-22-024801

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