Cynata Therapeutics Ltd., of Melbourne, Australia, said, following a pre-investigational new drug meeting with the FDA's Office of Cellular, Tissue and Gene Therapies, it has received written advice from the agency on the regulatory approval path for its Cymerus mesenchymal stem cell (MSC) products in the U.S. The FDA confirmed that the scope and substance of the company's chemistry, manufacturing and controls dossier is commensurate with its expectations, which indicates that Cymerus MSC products are expected to be of suitable quality for clinical trial use.