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GH Research submits complete IND hold response to FDA

GH Research (GHRS) announced that, in June, it submitted its complete response to the previously announced clinical hold of its Investigational New Drug Application for GH001 to the U.S. Food and Drug Administration. “We are thrilled to have submitted our response to the FDA ahead of schedule, addressing their clear requests with comprehensive data and completed toxicology studies. We remain fully committed to working closely with the agency to bring GH001 to patients,” said Dr. Velichka Valcheva, CEO.

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