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Message: Re: Possible news releases for Resverlogix based on Amarin/ESC/AHA

"Sounds great,... will make the next 4-5 weeks go faster. Am surprised the pps is not already starting to move up."

It may seem like a slow period, but a lot going on behind the scenes for sure. Abstract submission deadlines for AHA, ASN, CTAD (Asia), CTAD (San Diego) over the next 1-6 weeks. Three publications in various stages of the review process. Posters and symposium presentations being finalized for ESC and EASD. News releases being pre-emptively written.  

As for BETonMACE, the last study visits occurred between 4/18/19 to 6/12/19. So all patients have now been off drug for approximately 2-4 months. All patient final safety visits concluded a month ago on 7/8/19. This likely means that no new patient samples collected or patient testing done for at least a month now. Over 225 of the target 250 MACE events were adjudicated as of 4/18/19. The adjudication process for the remaining ~25 should be done by now meaning that there are likley at least 250 adjudicated events right now. Additional adjudicated new events that occurred after 4/18/19 will increase the final total to beyond 250.

There are likely very few left remaining to adjudicate since the last study visits concluded 4/18/19 to 6/12/19 and final safety visits concluded 7/8/19. As stated in the news releases, "Additional MACE (over 250) that accumulate during this period will be added to the results while not slowing down the trial’s move towards final database lock.BETonMACE database lock likely in the next 10 to 40 days (assuming database lock 2 weeks prior to top-line, and top-line in September) whenever all the queries are resolved and regardless if any lagging events have been adjudicated. In the latest Zacks report, there was a footnote with example queries that read "Examples of queries include confirmation of last dose date or acquiring case notes from treating hospital when MACE events happen."

elsewhere.

Tick tock!

BearDownAZ  

 

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