We are grateful to the patients who have
chosen to participate in our previous
and ongoing clinical studies
Before a new therapy can be made available to the general public, multiple studies involving healthy volunteers and patient volunteers must be conducted to evaluate the safety and effectiveness of the therapy. These may involve a new treatment (also referred to as a clinical trial) or could be an observational study. Potential new medicines need to be extensively evaluated in multiple clinical trials to understand their safety and effectiveness. In the United States, these studies are regulated by the Food and Drug Agency (FDA), and in other countries, by similar regulatory bodies.