OM #2

During the reporting period the remaining nonclinical activities enabling the further (long-term) clinical testing of the islet replacement product candidate were completed and submitted to the FDA. This included the audited, final GLP study report for which the findings were supportive of the safety of the product candidate during long-term implantation.  Additional activities included clinical trial start-up activities which enabled the initiation of the clinical testing (the clinical trial itself is outside the scope of this project but also began during the reporting period).  The activities concluded the nonclinical development and testing of the product candidate under this award.