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Message: What would a successful BETonMACE Top-Line Data Announcement Look Like?

Iconoclast posted "I asked Paul Moon whether we will get an Amarin like data release (which was "RRR was 25%...").  He said absolutely not. He explained that such detailed information is meant to be given out in conferences.  He said Amarin was way out of line in giving out RRR data...and got into trouble with conference organizers for letting the whole cat out of the bag.  RVX has learnt from this and will not repeat Amarin's mistakes."

Iconoclast thank you so much for sharing this information. So it sounds like the expected September 2019 BETonMACE top-line data announcement will just be a statement of whether or not BETonMACE met its primary endpoint with statistical significance. If so, then the %RRR likely won't be revealed until one of the November major scientific conferences (see 2019 Potential Event List). American Heart Association (AHA) and American Society for Nephrology (ASN) meetings in November are likely candidates.

We might still expect to get some key news releases leading up to top-line and full data, as described in this post: Possible news releases for Resverlogix based on Amarin/ESC/AHA

Koo asked "So how will RVX express topline results come September other than %RRR when Topline is "Time To First Occurance"?"

Here are a few posts that have previously covered the topic of what a BETonMACE top-line data announcement may look like. They link to several example cardiovascular outcomes trials top-line data announcements. The most recent of the post below is this one from June 30, 2019: Re: Pfizer working with Zenith but not Resverlogix....Is 3 a crowd?. The copied paragraph below is from the June 30, 2019 post and focuses on the top-line announcements that simply stated whether or not the study met its primary outcome with statistical significance; the magnitude of the effect (the %RRR) was not disclosed in the top-line announcement and this %RRR info was reserved for later disclosure with full data at a major scientific conference and/or publication of data. The only link below that wasn't active anymore seems to be for the Novartis CANTOS trial for canakinumab, so you'll need to search the Novartis archive for that one.

"Most of the time in cardiovascular outcomes trials, the news release is simply a statement that the trial succesfully met its primary endpoint without any futher details in the top-line. In these cases, the %RRR and other detailed info are shared at a later date at a major scientific conference. This was true for CANTOS trial for canakinumabEMPA-REG OUTCOME trial for empagliflozinDECLARE TIMI-58 trial for dapagliflozinREWIND trial for dulaglutideSUSTAIN-6 trial for injectable semaglutideLEADER trial for liraglutideFOURIER trial for evolocumab and REVEAL trial for anacetrapib. These are just several examples and are not exhaustive of recent CVOTs. However, the point is that the norm is to have bare minimum info in the top-line and have details come out at a later date such as full data presentation at major scientific conference. In my opinion, this is the most likely format of news release that we will see for BETonMACE."

Here are a couple more posts on the same topic, but many of the links are no longer active and most of the info is redundant with what is in the June 30, 2019 post.

March 30, 2019: Re: What would a success NR look like?

July 13, 2018: Re: Top-Line, Primary Outcomes, Secondary Outcomes, Exploratory Outcomes, and Alzheimer's/Cognitio...

Additionally, the topic of the Kaplan-Meier analysis of the data was covered in this post from March 20, 2019: Re: RRR Calculation. Lots of links in that post to help folks understand the importance of the time factor in time to first occurence of 3-point MACE.

BearDownAZ

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Aug 10, 2019 10:09PM
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