International Stem Cell Corp. (ISCO) Announces Completion of Pre-IND Meeting with FDA for Parkinson’s Disease Program
Today before the opening bell, ISCO announced that it had completed a pre-investigational new drug meeting (pre-IND) with the US FDA, thereby completing its discussions with the administration about the company’s Parkinson’s disease cell therapy. The company received feedback and input from the FDA on its proposed pre-clinical plan, manufacturing approach, and clinical study design necessary to file the IND. We're pleased with the outcomes of the meeting with the FDA," said Yale School of Medicine Professor D. Eugene Redmond Jr. MD, who is leading ISCO's pharmacology/toxicology study. "The FDA's feedback has provided clear direction for the remaining studies required…