Filed On May 19, DiaMedica Therapeutics A Complete Clinical Hold Response With FDA For Clinical Hold On A Phase 2/3 Clinical Trial Of DM199; Response With FDA Requesting Clinical Hold Imposed On Phase 2/3 Clinical Trial Of DM199 For AIS Be Lifted
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DiaMedica Therapeutics has filed a complete clinical hold response with the FDA, requesting the lifting of the clinical hold on its Phase 2/3 trial of DM199 for acute ischemic stroke (AIS). The response includes a protocol amendment to reduce the dose and incorporate additional measures to reduce the risk of severe hypotension.
May 22, 2023 | 9:17 pm
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DiaMedica Therapeutics filed a clinical hold response with the FDA, requesting the lifting of the clinical hold on its Phase 2/3 trial of DM199 for AIS.
The lifting of the clinical hold on DiaMedica's Phase 2/3 trial of DM199 for AIS would be a positive development for the company, allowing it to proceed with the trial and potentially bring the treatment to market. This could have a positive impact on the company's stock price in the short term.
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