An analysis of the Study II clinical data (with 3 patients fAn analysis of the Study II clinical data (with 3 patients from Study Ib) provides the following interim assessments: 1) 7/10 patients (70.0%), who achieved a CR at 90 days continue to demonstrate CR at 180 days 2) In the total population of 33 patients (@ 90 days): i) 42.4% achieved Complete Response (“CR”) ii) 12.1% achieved Partial Response (“PR”) iii) 21.2% are Pending iv) 24.2% achieved No Response (“NR”) Hence, the potential for CR is up to 75.8%** for the interim clinical data analysis. Note**: Assumes both PR and Pending data are clinically determined to be CR at a later assessment date. 3) In the total population of 18 patients (@ 90 days), who received the optimized treatment: i) 44.4% achieved CR ii) 11.1% achieved PR iii) 38.9% are Pending iv) 5.6% achieved NR Hence, the potential for CR is up to 94.4%*** Note***: Assumes both PR and Pending data are clinically determined to be CR at a later assessment date for the interim clinical data analysis. In summary, for patients who received the primary optimized Study II Treatment versus the original Study II Treatment (90 days), there is a 5% increase in CR and a 77% decrease in NR.