Ann: Zantrene AML trial in Israel advances to Phase 2, page-124

The 505(b)(2) pathway just allows you to include outside clinical studies as part of your data package. To do this these external studies have to be comparable to your studies. If the historical studies were all single agent studies and your studies are all combination studies then they are not comparable.

While the Sheba study provides interesting clinical data on bisantrene (especially its ability to work in highly pretreated and refractory AML patients), it is not on any approval pathway.

The biggest value Sheba provides is demonstrating that bisantrene is still relevant in a modern context. For many investors the historical data is interesting (to some of us it is more than interesting), but it is not the same as knowing that bisantrene still works despite patients having much more treatment options today. In the past (1980s) AML patients had one treatment option and then it was onto at most one experimental treatment. Today AML patients have hundreds of experimental options and patients are reaching 7,8, or even 9 prior lines of treatment. If a drug works after 1 prior line of treatment is very different than if it works after 8 prior lines of treatment.