DM indicated that the BETonMACE recruitment was a little behind, which triggered a clause in their deal with the contract research organization to bring in Russia (20 sites, 200 patients) as another country in the trial. This will be paid for by the contract research organization. Additionally, Taiwan will begin recruiting in Q1, being paid for by Hepalink.
DM again stated that they hope to add US sites for BETonMACE but no guarantee. Meetings with Endocrine/Metabolic division of FDA have occurred and there will be continued discussions/meeting in Q1 2017. They will update the public with meeting results/outcomes as they occur, hopefully Q1 2017.
DM indicated that the Phase 2 BETonDialysis renal trial with apabetalone will launch early next year and will be in United States. IND filing Q1 2017. FDA interactions with cardio/renal division for this renal trial have been positive; positive feedback on trial design and positive instructions to enhance program. Looks to be a 6 month crossover design trial with 30 patients, so this Phase 2 should complete next year if I am interpreting the timeline correctly.
Slide 8 of the presentation was a really nice comprehensive overview of the other indications that they investigating pre-clinically with some ready or close to ready to proceed to trials.
Unless I missed it, there was no update of the status of the licensing deal, no updates on the confirmed a second clinical compound IND candidate that was mentioned at the October R&D update, and no update on any of the 7 compounds chosen for follow-on testing (including RVX-206, RVX-641, RVX-2101, RVX-2113) that were mentioned at the R&D update. DM still mentioned 2 more analysts and 2 more publications in the works. Not sure if we'll see those by year's end or next year. I wasn't there, so I missed the AGM portion and post-webcast Q&A. I'm not sure if DM provided any further clarification on the royalty preferred share issue or anything else during those portions of the meeting.
