Ann: US FDA Orphan Drug Designation Awarded to RC220 Bisantrene, page-61

Congratulations Dr.at and the Race team. This was quite left considering we were expecting the toxicology Ann next. Couple of questions:

1. Given the FDA review of RC220 and the ODD designation does it mean that the toxicology and pharmacology announcement is largely procedural- in other words is FDA’s ODD approval implicitly confirming the studies meet the pharmacology and toxicology requirements?

2. What month was the ODD request submitted?

3. As you previously mentioned that there are numerous AML trials underway, what is the potential for another drug to get the ODD & marketing approval prior to RC220?

4. Do you plan to apply for orher approvals/ designations like the BTD or Fast track approval?

Thanks in advance.