India, Aug. 11 -- ITM Isotope Technologies Munich said the U.S. Food and Drug Administration has declined to approve its application for ITM-11, an investigational treatment for gastroenteropancreatic neuroendocrine tumors (GEP-NETs), citing concerns related to manufacturing.
The FDA issued a Complete Response Letter on August 7, stating that the application could not be approved in its current form because of issues involving chemistry, manufacturing and controls, as well as a third-party commercial manufacturing facility. ITM said the agency did not identify concerns with ITM-11's clinical or nonclinical data or its safety profile.
The company's application was supported by results from the Phase 3 Compete trial, in which ITM-11 demonst...