The FDA has recommended a standard 90 day in vitro toxicology study comparing the combination product with each active component in separate arms to support the proposed phase IIb trial. This will provide further support for the safety of the compound which was well tolerated in the Company’s Phase IIa human study... DiaMedica's Press Release -
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- DiaMedica : pre-IND FDA Guidance on DM-71
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Tuesday, May 27, 2008
DiaMedica : pre-IND FDA Guidance on DM-71
May 14, 2008 – DiaMedica Inc. (TSX-V:DMA), a drug discovery and development company focused on novel treatments for Type 2 diabetes, today announced that it has received feedback from the U.S. Food and Drug and Administration (FDA) on its pre-IND filing for DM-71, the Company’s lead compound.