PolarityTE Announces Submission of Complete Response to FDA’s Clinical Hold Correspondence for SkinTE® Investigational New Drug Application

December 20, 2021

PolarityTE, Inc. announced that it has submitted its complete response to the U.S. Food and Drug Administration’s (FDA) clinical hold correspondence regarding its Investigational New Drug (IND) Application for SkinTE^® with a proposed indication for chronic cutaneous ulcers.  As previously disclosed, the primary hold issues are certain Chemistry, Manufacturing, and Control (CMC) items, including the assay to demonstrate the potency of SkinTE.

The Company’s complete response to the hold issues was submitted on December 17, 2021.  Under FDA’s standard practices and regulations, if FDA agrees that the Company’s response is complete, a decision from FDA should be communicated to the Company within 30 days, subject to potential delays or other unforeseen circumstances.

Richard Hague, Chief Executive Officer and President of PolarityTE, commented, “I am incredibly proud of the extraordinary efforts of our entire team in preparing our complete response to the Agency.  We believe that our response is robust and compelling in terms of addressing the issues raised by the FDA.  We cannot predict how the Agency will respond or whether the IND will be accepted based on our complete response, but we look forward to receiving the Agency’s feedback in due course.  We remain completely focused and fully committed to obtaining clearance of SkinTE’s IND application as soon as possible so that we can commence our first pivotal study, and we look forward to continued engagement with the Agency as we work to advance SkinTE through the regulatory process.”

View the original press release here »

SOURCE PolarityTE, Inc.