Submission of Complete Response to Clinical Hold
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Hemogenyx Pharmaceuticals plc (LSE: HEMO) announces the submission of a complete response to the previously announced Clinical Hold ("CH") of the Investigational New Drug ("IND") application to the US Food and Drug Administration ("FDA") for HEMO-CAR-T. A complete response is necessary to apply for the lifting of the CH which is needed to obtain consent from the FDA to commence Phase I clinical trials of HEMO-CAR-T.
Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "We are pleased to have filed a complete response to the FDA addressing their concerns that resulted in a CH of the HEMO-CAR-T IND. We look forward to becoming a clinical stage biopharmaceutical company once consent is received from the FDA."
About AML and CAR-T Therapy
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