7. What was the clinical development of DONA™?
DONA™ has been evaluated in clinical trials in more than 6000 osteoarthritis patients to date. The most recent clinical development of DONA™ has been conducted according to the strict guidelines published by scientific organizations, such as the Osteoarthritis Research Society International (OARSI), and Health Regulatory Agencies such as the Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA). Indeed, this product has been approved as a prescription drug for the treatment of osteoarthritis in more than 60 countries around the world, according to an FDA-like review process.
The comprehensive clinical trial program performed with DONA™, includes short-term studies (up to 6 months) on the signs and symptoms of osteoarthritis and long-term studies (up to 3 years) on the modification of joint structure and disease progression. These studies are published and they are summarized in details in the Product Monograph of DONA™.
These statements have not been evaluated by the Food & Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.