Thank you to Masila, PolarOne and any others that have let us know you will be at the AGMs for Resverlogix and Zenith tomorrow and taking notes to share. It is very much appreciated from folks like me who won't be in attendance. Past notes from AGM and other meetings/conversations shared by the likes of Tada, Imtesty, Fouremm, Masila, Growacet, Tundup and others I am surely missing are so helpful. Hopefully the slide deck will be posted at the time of presenation even though the webcast won't be live and archive not available to view until later that evening.

For those in attendance, I just have a few issues to ask about in case they are not addressed in the presentation:

1) The obvious one....details on the plan/status of the SSRA. Is it still planned? Have 75% of planned events (188 events) been adjudicated yet? Will the SSRA plan be abandoned akin to what happened with the planned futility analysis at 50% of planned events (125 events) that never occurred?

2) Related....will the company provide updates as the # of events approaches 250 and when the last patient study site visit has occurred. How long is the adjudication process taking after a suspected 3-point MACE event has occurred? The ongoing (and soon to be reporting top-line data) REDUCE-IT trial by Amarin (discussed here) provided these types of updates. Will Resverlogix?

3) Another obvious one.....is top-line data still expected by end of 2018, or is the revised target for top-line data now 2019?

4) I would appreciate an explicit statement that BETonMACE protcol is amended to allow for patients to be dosed beyong 104 weeks. There has been no official statement from the company on this and the ClinicalTrials.gov listing is outdated (last update 9/27/17) and does not reflect this. If I recall, the only items that have mentioned this so far are the AAIC and ERA-EDTA posters for the cognition and renal sub-studies, respectively, that indicated that at completion patients will have been dosed for between 6 and approximately 36 months. 

5) Revised timeline for start of Fabry disease, Renal/dialysis and pulmonary arterial hypertension (PAH) trials that are listed on ClinicalTrials.gov. The PAH trial was just listed and has an estimated start date of November 2018. The Renal trial estimated start date has been revised a few times and the last one is now outdated and lists estimated start date of July 2015. The Fabry trial estimated start date has also been revised previously, but currently lists estimated start date of Sept 30, 2018.

6) Have any US patients been enrolled in BETonMACE or has Resverlogix made the decision to not enroll any US patients in BETonMACE?

7) Does Resverlogix expect the top-line data announcement to only provide guidance on the primary outcome (time to first occurence to 3-point MACE), or will this top-line data announcment also contain guidance on the renal and cognition sub-studies. If the sub-studies are not included in this first top-line data announcement, when will they be announced (at BETonMACE full data presentation? As another top-line data announcment?

Thanks,

BearDownAZ