secwatch.observer — SEC 8-K summary
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Issuer:     DiaMedica Therapeutics Inc. (DMAC)
CIK:        0001401040
Form:       8-K
Filed at:   2023-05-22T23:59:59+00:00
Accession:  0001437749-23-015488
Event type: regulatory
Sentiment:  neutral
Materiality: 0.70
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

DiaMedica files clinical hold response with FDA for ReMEDy2 trial of DM199 in AIS
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- Filed complete clinical hold response with FDA on May 19, 2023 to lift hold on Phase 2/3 ReMEDy2 trial of DM199 for acute ischemic stroke.
- Protocol amendment includes reduced IV dose of DM199 and additional measures to reduce risk of severe hypotension in participants.
- Investor presentation on ReMEDy2 status furnished as Exhibit 99.1 for use at conferences and meetings.
- No FDA decision timeline disclosed; clinical hold remains in effect pending review.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1401040/000143774923015488/0001437749-23-015488-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1401040/000143774923015488/dmtp20230522_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-23-015488

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