Re: The 3 inflection points: SSRA, Top-Line, Full Data
in response to
by
posted on
Sep 10, 2018 10:33AM
Narmac,
I am not 100% sure which of the involved parties (i.e. DSMB, Clinical Steering Committee, Resverlogix) have access to the data in between top-line announcment and full data release. However, based upon my following of other recent CVOT trials, there will be no drips and drabs in between. Things typically stay very hush hush.
I expect positive SSRA results, top-line data announcement and full data reveal to each benefit the share price significantly for the reasons I detailed in my original post in this thread. Each subsequent inflection point will build upon the prior, in my opinion, by augmenting the potential, credence and anticipation of apabetalone being a blockbuster. Perhaps the most significant of the three for share price will be top-line data announcment. It may not be until top-line data reveal that the world really starts paying attention to Resverlogix. But there will be no ignoring this company and this drug if the BETonMACE trial gets the top-line data announcment we are all hoping for!
A great contemporary CVOT trial to be paying attention to is Amarin's REDUCE-IT trial. REDUCE-IT is investigating whether reducing plasma triglycerides (TG) in patients with hypertriglyceridemia will reduce cardiovascular events. Icosapent ethyl (Vascepa), a highly purified ethyl ester of a long-chain omega-3 fatty acid called eicosapentaenoic acid (EPA), that reduces plasma TG without raising LDL-cholesterol.This provides an example blue print of the type of news releases and timelines that may flow between an interim analysis and top-line data reveal. I think Amarin plans to announce full data at American Heart Association in November 2018 but they are planning to release top-line data this month.
August 2017: Amarin announced results from an interim efficacy analysis after 80% of the 1612 target events were adjudicated.
January 2018: Amarin announced that it had reached the 90% mark for reported and documented primary events.
April 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 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.
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. However, the statement below from Amarin's June 2018 news release is very important to keep in mind about the potential time between last study visit and reporting top-line results.
"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."
One additional inflection point for BETonMACE that I didn't mention before could be a news release from the company that they estimate to have reached the targeted 250 MACE events and/or last patient study visit. This would be expected to occur prior to top-line data announcement. We will hopefully get more guidance on Wednesday at the AGM, but one possibility is that 250 events/last study visit is reached near end of 2018 but the "close out" time period described above for REDUCE-IT results in top-line data for BETonMACE not coming out until 2019.
All just my opinion. Do your own due diligence. Not investment advice. Good luck to all.
BearDownAZ