Just over a week until BIO CEO 2019 

Resverlogix Tuesday Feb 12th 2:00 to 2:15 PM

Zenith Tuesday Feb 12th 2:30 to 2:45 PM

Just for reference here is my latest 2019 schedule of events.

Now, let's  revisit this "The Waiting Game" thread since there are still unanswered questions

"Will we hear anything out of Resverlogix prior to BIO CEO & Investor Conference February 11-12, 2019 in New York?"

Well, we got news of the Hepalink Private Placement last week, but what about BETonMACE news?

"Is that MACE rate range still accurate or has it been less than 10 per month over the past 4 months?"

Still to be determined. Assuming that BETonMACE was at around 200 events at the AGM on 9/12/2018, then fast forward to next Tuesday 2/12/2019 (coincidentally the date of the BIO CEO presenation) would add an additional 50 events at the low end of the event range (5 months X 10 events/month). I'm sure we are all anxiously looking forward to an update next week. 

"Are they planning to make an announcement once 250 events have been reached and dosing has ended?"

There is ambiguity as to whether the events reported in the latest corporate updates are adjudicated or not. However, since this original post, there does seem to be clarity that reaching 250 adjudicated events would require material disclosure. And unless they have changed protocol, dosing would end once 250 events have been adjudiated. So it seems that the answer to this question above is yes.

"Is there a planned BETonMACE rationale and design publication in advance of top-line data?"

None yet. I hope this is still coming. It would be great to have a more detailed peer-reviewed article that includes similar info as what was in the AHA 2018 BETonMACE design poster.  

"Will there be an end of January surprise with Resverlogix/BETonMACE getting a late breaking clinical trial slot at the March ACC 2019 meeting?"

Resverlogix was not on the list of LBCT presentations. But they do have a couple other abstracts they will be presenting at ACC 2019 (see the latest 2019 schedule of events).

"Since BETonMACE has been fully enrolled for several months now, certain aspects of the original trial design changed and since BETonMACE ClinicalTrials.gov hasn't been updated since September of 2017, when will Resverlogix get their act together and update the status of the ClinicalTrials.gov site? Are they leaving the door open for performing an interim analysis and opening enrollment back up?"

Since this original post, the trial listing was updated to indicate that the trial is active, but no longer recruiting. I was also hoping for additional trial amendments to appear, such as language to indicate that the allowable dosing period was extended beyond the stated 104 weeks. Perhaps if a trial rationale and design publication comes out, along the lines of the AHA 2018 BETonMACE design poster, these details will be included.  

"Since it is pretty clear that top-line data won't be coming before January 31, 2019, how will Resverlogix deal with the Third Eye loan requirement that Growacet reminding us of last month?"

Well, we beat this topic to death last week so I won't comment any further here.

"What market conditions or catalysts is Resverlogix waiting for to pursue the US listing?"

Still unanswered.

Lastly, I'll re-post this list of order of events that was included in an earlier post. I lightly editted the original and also added 2c for uncertainty of how "off-treatment" events that happen after end of dosing are treated.

1) 250 adjudicated events achieved, triggering end of dosing and material disclosure.

2a) Completion of adjudication to evaluate remaining unconfirmed events that occured prior to end of dosing. This will possibly move more unconfirmed events into the confirmed/adjudicated category. 

2b) Last patient follow up safety visits (can occur concurently with 2a).

2c) Adjudication of any "off treatment" events that occured AFTER dosing ended. I'm not sure if how these affect timelines, database lock and data analysis but just wanted to throw this in here.

3) Database lock (might occur prior to completion of 2a and/or 2b and/or 2c).

4) Crunching and analyzing the data

5) Top-line data release for primary outcome (possibly CKD and cognition sub-study results too if available).

6) More crunching and analyzing the data

7) Full primary outcome data presented and published

8) CKD and cognition sub-study results reported if not done earlier

9) More data analysis

10) Pre-specified comparisons for primary outcome reported

BearDownAZ