PolarityTE Says It Developed Strong Plan To Address Clinical Hold On IND For SkinTE - Quick Facts

Providing an update regarding the FDA hold on its Investigational New Drug Application (IND) for SkinTE on Thursday, biotechnology company PolarityTE, Inc. (PTE) said it has developed a strong a plan to address the issues FDA identified and is currently working diligently to prepare a complete response.

PolarityTE has also informally engaged with the FDA on certain points raised by the agency regarding the proposed potency assays that the Company plans to implement.

PolarityTE believes the opportunity to receive additional guidance from FDA prior to submitting a complete response could help the Company comprehensively address the hold issues identified by FDA to ultimately support an IND acceptance.

The FDA had placed a clinical hold on August 24 on the study proposed in its IND for SkinTE with a proposed indication for chronic cutaneous ulcers. The IND application was filed on July 23, 2021.

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