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Message: Top-line vs. Full Detailed Clinical Trial Results

"I guess the gist of my question is....If it is looking like the company is foregoing a top-line announcement, is it fair to think that it means the trial results news isn't that impressive, or even not meeting the trial end-points?"

The Sanofi-Regeneron ODYSSEY trial with Alirocumab was the second CVOT with a PCSK9 antibody and was presented at ACC in March 2018. As previously discussed, there was no top-line data announcement prior to presenting the full results. A full year prior to this in February 2017, Amgen reported top-line results for the FOURIER trial with Evolocumab, and then presented and published full results May 2017. So although ODYSSEY was important, it was no longer the first in class to report CVOT results for a PCSK9 antibody. 

A similar example is for the SGLT2 inhibitors canagliflozin from Jansenn vs. empagliflozin from Boehringer Ingelheim and Eli Lilly. EMPA-REG OUTCOME with empagliflozin was the first SGLT2 inhibitor CVOT to report out (top-line August 2015, full data at EASD in Sept 2015). The CANVASS program (two trials CANVAS and CANVAS-R) for canagliflozin did not issue top-line data and reported full results at American Diabetes Association in June 2017

Why did they not report top-line? I don't know. CANVASS and ODYSSEY were still great results. Maybe it was because neither one was a first in class CVOT to report out? Maybe it was a requirement of the ACC and ADA embargo policy? Maybe it had something to do with timing? 

As for BETonMACE, apabetalone is a novel, first in class therapy so it won't have the same problem as for the PCSK9/SGLT2 examples above. In my opinion, I 99.99% expect a top-line data news release (positive or negative) in H1 2019 UNLESS Resverlogix has decided to submit for the ACC 2019 late-breaking clinical trial session (deadline was this afternoon). If accepted (will be announced by end of January 2019), then Resverlogix may (like almost every other CVOT) or may not (like ODYSSEY at ACC 2018) issue a top-line results announcement prior to the ACC 2019 meeting presentation. I don't think this decision would necessarily have anything to do with positive or negative findings. 

From the investor and company finance perspective, it would be much better to issue top-line data announcement. The share price may move some with anticipation of results but will likely only break out with reveal of top-line or full results. In the event that top-line data is ready prior to ACC 2019, it would benefit the company and investors to issue top-line and capitalize on the share price appreciation as opposed to sitting on all data until ACC 2019. Of course, all of this assumes positive data!

Come end of January 2019, if Resverlogix/BETonMACE isn't on the schedule, then all of this "Will there be a top-line data announcement?" discussion is now irrelevant. If no ACC 2019, then look for top-line press release in advance of full conference presenation at a later date. But if Resverlogix/BETonMACE do get an ACC 2019 presentation, we may or may not see top-line data and in my opinion this decision would have no bearing on the positive or negative nature of the findings.

BDAZ

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