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PolarityTE Provides Corporate Update | Financial Buzz


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PolarityTE, Inc. (Nasdaq: PTE), a biotechnology company developing and commercializing regenerative tissue products and biomaterials, is pleased to provide this update. Our focus is on building shareholder value by pursuing pre-market approval for SkinTE® from the U.S. Food and Drug Administration (FDA) through submission of an investigational new drug application (IND) and eventual biologics license application (BLA), and protecting our intellectual property.
Regulatory Update
Over the last several months, the Company has had meaningful interactions with the FDA regarding the Company’s planned IND for SkinTE. Through these interactions the Company gained valuable insight regarding the critical information it expects to include in the IND, and believes it remains on track to file the IND for SkinTE in the second half of 2021. ....

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