PolarityTE Study Placed on Clinical Hold After FDA Feedback

 PolarityTE Inc. said its study has been placed on clinical hold after it received feedback from the U.S. Food and Drug Administration related to its investigational new drug application for a product for chronic cutaneous ulcers.

The company on Tuesday said the FDA provided feedback that certain chemistry, manufacturing and control items need to be addressed before proceeding with the study.

PolarityTE said the FDA told the company it would issue a clinical hold letter with details on the basis for the hold by Sept. 21.

"We are actively working to address the issues identified by the FDA and our team plans to respond to the agency's feedback as expeditiously as possible, and we are hopeful that we will be able to resolve any open items," Chief Executive David Seaburg said.

https://www.marketscreener.com/quote/stock/POLARITYTE-INC-33339222/news/PolarityTE-Study-Placed-on-Clinical-Hold-After-FDA-Feedback-36234105/