Growacet, that is my understanding of off-label use too. Sumpup, I never suggested that apabetalone couldn't be used off-label once approved for its initial indication(s). I was simply making the point that BETonMACE secondary (eGFR change) and exploratory (MoCA change) outcomes may have no bearing on the NDA/MAA approval, or rate of approval, of apabetalone for the primary MACE outcome indication. I was also making the point that even with stellar eGFR and/or MoCA changes, a Phase 3 confirmatory trial with renal and cognition as primary outcome may be required for NDA/MAA approval for marketing and label for these expanded indications. It all depends on the trial results and what indication(s) Resverlogix actually applies for in the NDA/MAA. It's possible apabetalone could be approved based on BETonMACE alone for indications beyond the BETonMACE primary outcome and beyond the specific BETonMACE population. But it's also possible that further trials will be required for renal and cognition expanded NDA/MAA approval. It's somewhat of a moot point in the short term, since likely Apabetalone approval will first be limited to the diabetics with low-HDL and recent ACS event anyways. If these folks are prescribed apabetalone for MACE reduction, they would receive these potential renal and cognition benefits anyways since they would already be on the drug. And with further clinical trials and ongoing real world use of apabetalone, it would eventually get label expansion if appropriate. If BETonMACE is successful, there will be more trials. Looks at any top cardio/diabetes drug and you will appreciate their clinical trial resume. BETonMACE will be just the start, if successful.

BearDownAZ