Clinical Trial Site preparations are being performed by our CRO in India, Om Sai Clinical Research Pvt. Ltd., and associates in DRC. The CRO personnel have visited the site several times, despite travel restrictions, and changing flight schedules and cancellations, as required for the preparations. Enrollment and dosing of patients is expected to begin after the staff training is completed in a few weeks.

This Phase II clinical trial was previously delayed because of change in the clinical trial site away from Kinshasa. An on-site examination of the new site by our CRO found that the new site required substantial amount of preparation in readiness for conducting the clinical trial. Our preparations experienced additional delays after the travel restrictions within DRC and internationally were imposed subsequent to the May 17 declaration of a Public Health Emergency of International Concern (PHEIC) due to an Ebola outbreak in DRC.