Corestem's Stem Cell Therapy Phase 3 Clinical Trial Paused by US FDA

[Asia Economy Reporter Minji Lee] Corestem announced on the 20th that the U.S. Food and Drug Administration (FDA) has put on hold the Phase 3 clinical trial application review for its stem cell therapy product, Neuronata-AL.

A company official stated, "The review of the clinical trial application was put on hold due to insufficient data related to characterization analysis, manufacturing, and quality control," adding, "We will prepare new data and respond promptly to obtain clinical approval as soon as we confirm the detailed reasons for the hold within 30 days."

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