ASX Hot too!, page-304

Back to the original plan - Adult RCT or propensity matched control- interesting to note the royalty based chats with financial groups. The new Chair commenting on maximising shareholder value earlier today.

Eric Rose: Good. We have had 10th interest in our product on the part of adults oncologists that face the same problem as the pediatric oncologist. Whether or not it will – what type of trial we’re discussing with members of the CIBMTR now there is a clinical trials group that is supported by the NIH that we’re in discussion with about doing a trial on adults that presumably will extension the label to that age group as well, but the design of such a trial is still outstanding.

Silviu Itescu: Yes. And I think we have flexibility in thinking about the degree of severity in the adults whether we use a randomized control design or whether we use a propensity matched control design. I think all of those are on the table, and they will form part of our ongoing discussions with the FDA.

Sami Corwin: Great. And then just one more if I can. Considering you plan on running two Phase 3 trials and potentially launching the aGVHD product. Do you think you have enough cash on hand to accomplish all near-term milestones? Thank you.

Silviu Itescu: Yes. As I said earlier, there are multiple alternative ways by which we may fund these various trials. And they include collaborations as Eric just mentioned with academic groups like the – like NIH or registries like CIBMTR, for example, and that that would have a substantial impact on our resource allocation. Secondly, there are financial groups that – that we are in discussions with who are interested in potentially royalty based structures that would again, defer our spend requirements. And thirdly, we have access to up to an additional $40 million in pre-arranged debt structures with our existing facilities that become available post FDA approval, should we want to access them.