"Bear - I was going to ask what you have seen in the past for time to lock data base after safety follow-up completion. This is the area that has been left murky. From your post, I can see that is your question also.....The time to lock the database is an unknown so if you have any past experience in this, it would be appreciated."

No I don't have much experience in this. I don't think database lock is a material event requiring disclosure, so there may not be much info out there on this. However, there is a recent example of Amarin's REDUCE-IT study that may be informative. Of course, the target number of events, number of patients, event rates and other trial design aspects are quite different between BETonMACE and REDUCE-IT. But it still provides a nice example timeline for the duration between milestones. BETonMACE had 2425 patients, 250 target events and a goal of ~3600 patient years accumulated over ~3.5 years. REDUCE-IT had about 8200 patients, ~1600 target 5-point MACE events (including ~1050 3-point MACE events), and ~35,000 patient years (not a typo) accumulated over about 6.5 years.Keep in mind that BETonMACE is a much smaller trial than REDUCE-IT and it is reasonable to expect the timelines to be shorter for BETonMACE.

April 4, 2018: Amarin announced that REDUCE-IT is estimated to have reached the onset of the targeted 1,612 MACE events, anticipates that MACE from the study will be adjudicated through Q2 2018, and on track for reporting top-line results before the end of Q3 2018.

June 28, 2018: Amarin announced that the last patient study visit had occurred and reiterated that it anticipates having top-line results before the end of Q3 2018.

Sept 24, 2018: Amarin announced top-line results.

The June 2018 Amarin news release had a great summary of the process copied below. Keep in mind that BETonMACE is a much smaller trial than REDUCE-IT and it is reasonable to expect the timelines to be shorter for BETonMACE.

"The time between commencing last patient study visits and reporting top-line results in other large outcomes studies reviewed by the company has been approximately five to seven months. There is no reliable correlation between the length of time needed to wind down a study (i.e., the time interval between commencement of patient last site visits and reporting top-line results) and the outcome of reported results of a study.  Amarin’s anticipation of reporting top-line results before the end of Q3 2018 is consistent with the wind-down timing of these other outcomes studies, each of which were conducted by companies much larger than Amarin.......As previously described, other important steps needed to complete the study include finalizing adjudication of reported events, including major adverse cardiovascular events (MACE) within the primary endpoint, securing final vital status data from inactive patients, and completing the review of data for consistency and completeness across more than 35,000 patient years in the trial."

RVXOT also wrote: "The times they have given are from fastest to July 17th to slowest to July 31st. This is of course with zero time to lock database after safety follow-ups. Adding some time for that gives maybe July 24th to August 7th."

How are you arriving at those dates? If safety follow ups conclude July 4th and no additional database cleanup or queries, the database could lock July 4.

BearDownAZ