WASHINGTON (dpa-AFX) - Biotechnology company PolarityTE, Inc. (PTE) announced Tuesday that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the study proposed in its Investigational New Drug Application (IND) for SkinTE with a proposed indication for chronic cutaneous ulcers. The IND application was filed on July 23, 2021.
The FDA provided feedback that certain Chemistry, Manufacturing, and Control (CMC) items need to be addressed prior to proceeding with a pivotal study. As a result, In accordance with standard practice and regulations, the FDA has advised that it will issue a clinical hold letter providing details on the basis for the hold to the Company by September 21, 2021.
PolarityTE previously disclosed that there was the potential for a wide range of outcomes with respect to its SkinTE IND submission, including but not limited to a clinical hold, and the Company is already formulating a plan to address the issues identified by the FDA.
Based on FDA feedback the Company is confident that the modifications made to its proposed clinical trial protocol in Wagner Grade 2 diabetic foot ulcers will enable this pivotal study to begin enrolling once the CMC issues are resolved.
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