WASHINGTON (dpa-AFX) - PolarityTE, Inc. (PTE), a developer of regenerative tissue products and biomaterials, said on Monday that it has filed its complete response to the U.S. Food and Drug Administration's or FDA's clinical hold correspondence for its Investigational New Drug or 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 said in a statement.
PolarityTE's complete response to the hold issues was submitted on December 17.
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