The company is conducting the final analysis on the Phase I clinical data
(expected by year-end), with a follow-up Phase 1b proof-of-concept trial in
1H16. Recall that Rock Creek's regulatory strategy is to complete a single-site
Phase Ib/IIa trial in EU and prepare data for a multi-site Phase IIb trial including
in the U.S. The FDA's approval for the Phase IIb trial is expected in 2016.