PTE - PolarityTE submits complete response to FDA's clinical hold for SkinTE application

PolarityTE (NASDAQ:PTE) has submitted its complete response to the FDA's clinical hold correspondence regarding its Investigational New Drug (IND) Application for SkinTE with a proposed indication for chronic cutaneous ulcers. Shares up 5% premarket at $0.41. 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. "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," commented Richard Hague, CEO of PolarityTE. The FDA placed clinical hold on PTE's SkinTE application in August 2021.

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PolarityTE submits complete response to FDA's clinical hold for SkinTE application