Re: What is Mr. Market saying about RVX?
posted on
Nov 26, 2018 03:56PM
"Maybe someone can chime in and clarify if there is typically a significant wait between 'end of adjudication' and 'top-line being known'."
I don't recall seeing an end-of-adjudication announcement for any CVOT trial that I recall. Typically, top-line results are announced shortly after adjudication is complete. As exemplified in a previous post, top-line data for CVOTs is usually just a simple statement of whether the primary outcome was met w/ statistical significance. Usually, no %RRR is stated. However, Amarin bucked that trend earlier this year by stating a %RRR in their top-line announcement. The lag/wait period is usually between top-line announcement and full data release at a major conference. Usually, the CVOT study is published in major journal simultaneously with full data presentation at major conference.
As I mentioned earlier in this post about ACC 2019 in March, it is possible that Resverlogix foregoes a top-line data announcement and presents the full data at ACC 2019 late breaking clinical trial (LBCT) session. That's what happened with Sanofi/Regeneron with their PCSK9 antibody alirocumab (Praluent) ODYSSEY trial that was presented in March 2018 at ACC. ACC 2018 accepted LBCTs were announced January 2018, and presented March 2018. If Resverlogix decides to enter a LBCT abstract for ACC 2019 (Dec 5th, 2018 deadline), we'll know by end of January if they get an accepted presentation.
We can also use Amarin's communications during the close of REDUCE-IT as a good example. Things should move faster for BETonMACE since it required less patients, less patient years and less MACE events. But in general, these are the kind of communications to expect.
June 28, 2018: AMARIN REPORTS LAST PATIENT STUDY VISIT HAS OCCURRED, AN IMPORTANT STEP TOWARDS COMPLETION OF REDUCE-IT™ CARDIOVASCULAR OUTCOMES STUDY
September 24, 2018: REDUCE-IT™ CARDIOVASCULAR OUTCOMES STUDY OF VASCEPA® (ICOSAPENT ETHYL) CAPSULES MET PRIMARY ENDPOINT
BDAZ