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Message: Re: Win or lose....one thing we know for sure

"Rosuvastatin subgroup looks much cleaner than this  subgroup for the Cantos study."

You may be right and I hope you are. Although Resverlogix initially wanted to do the trial only with rosuvastatin, the FDA/EMA regulators seemed to require atorvastatin group as well. The rosuvastatin/atorvastatin is a pre-specified analysis in BETonMACE according to prior communication to me by IR. Furthermore, various presentation slides have indicated that rosuvastatin/atorvastatin is a pre-specified subgroup analysis of the primary endpoint. 

But can a significant apabetalone effect only in the rosuvastatin group stand on its own in the context of missing the primary endpoint in the combined statin group? This is one of the biggest unknowns in my opinion. There was no explicit mention of the rosuvastatin subgroup hypotheses in the BETonMACE design and baseline data posters or publication. One could possibly infer this from the fact that the only two statins allowed in BETonMACE are atorvastatin and rosuvastatin. And the two statins are listed as separate interventions/treatments in the ClinicalTrials.gov listing. Maybe I am just naive, but it still doesn't seem clear to me.

If Resverlogix can rely on only the rosuvastatin subgroup alone, independent of the combined statin group results, then this is great and this boosts my confidence tremendously based on the post-hoc analyses of ASSURE. But if the combined statin group needs to succeed as well in order for the rosuvastatin subgroup analysis to be valid, then this paints a different picture.

Tick tock.

BearDownAZ

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