Based on the success of previous and present trials, we have designed and are in the process of implementing Phase IIb and Phase III trials in China, Taiwan, India, Norway/Sweden, and the United States.
Each clinical trial requires submission of an extensive application for review by and approval from the appropriate governmental agency (e.g. in the United States, the FDA). Applications have been submitted or are being prepared for each of the participating countries. Following application and review, the agency responds with questions. When questions regarding safety and potential efficacy have been answered, approval to initiate the trials is granted.