Debt: I'm in agreement with everyone here that the $117.6 million CAD debt is a head scratcher. I just emailed Sarah and Clayton too asking for clarification on this debt issue.

US/FDA involvement in BETonMACE: As for the US involvement in BETonMACE, we were told in December at the Annual Meeting regarding FDA interactions for BETonMACE with the Endocrine/Metabolic division that "Updated meeting results and outcomes will be made public as they occur – expected to occur in Q1 2017." Today's slide 19 is a far cry from providing updated meeting results and outcomes. We expect and deserve a more thorough explanation instead of a blindside from slide 19. 

What has been clear and is still clear is that the current BETonMACE trial, if succesful, will still be valid for filing the European Marketing Authorization Approval (MAA) for commericalization (selling and marketing) of apabetalone in Europe. However, it has been and still is unclear if the US/FDA will allow a new drug application (NDA) to be filed based off of the current BETonMACE trial. Perhaps Resverlogix has received guidance from the FDA that it may not approve the NDA for apabetalone without a US trial. That is just a guess. Or perhaps the FDA is still dragging its feet with a decision and Resverlogix is going ahead and planning for US BETonMACE just in case the NDA wouldn't be approved based on current BETonMACE. BETonMACE has been dosing for over 19 months and is expected to complete enrollment sometime H2 2017. Perhaps the window of time for including US patients has closed, since the last patients in the trial will only be dosed for 12 months.

BETonMACE enrollment: I was also hoping for a general update on BETonMACE enrollment. Last we heard, we were at just over 1200 in March. We've been told for several months now that Russia and Taiwan were going to be starting recruiting/enrollment in BETonMACE for some time now. Unfortunately, today's slides gave zero insight into the general enrollment status or the Russia/Taiwan status.

Phase 2a BETonRENAL: No update on the timeline of when the Phase 2 Renal trial will begin other than slide 28 indicating mid-2017 start. ClinicalTrials.gov lists June 15 as the anticipated start date, but still lists the trial as not yet recruiting. They anticipate a Phase 3 Dialysis and a Phase 3 CKD trial to begin in early 2019 along with the Phase 3 US BETonMACE in early 2019. 

Overall, I found this BIO International presentation to raise more questions than it answered. Which is unfortunate, because there already were a lot of unanswered questions. Now, the list just got longer......

BearDownAZ