DM: We can target quite a few diseases. Resverlogix's other advantage is that we have had the only repository of blood from long-term, bromodomain-treated patients. That means we have analyzed the blood and plasma samples of these patients in great detail and have applied these findings to other indications. We plan to expand into renal and Alzheimer's disease projects next year. Early this fall, we plan to announce a project targeting a pediatric orphan indication.

TLSR: How do pediatric orphan diseases fit into your strategy?

DM: The FDA may issue expedited coupons to companies pursuing pediatric programs in orphan indications to speed clinical trials and FDA reviews. These coupons are marketable and have sold for between $70M and $160M. We probably would monetize it, if we get one.

Here's the link:  https://www.streetwisereports.com/pub/na/disrupting-treatment-of-cardiovascular-disease-with-epigenetics-resverlogix-ceo-donald-mccaffrey

In the case of Breakthrough Therapy Status...if its not granted by the FDA/EMA (one or both) then I expect we'd hear nothing, as we heard nothing about their pursuit of an orphan indication 4+ years ago.