Although we don't know the full story of the FDA and BETonMACE, we must keep in mind that apabetalone belongs to an entirely new class of drugs (BET inhibitors) and that apabetalone flunked the primary outcome measure of the preceding Phase 2 trial ASSURE. Add on top of that the shifting endpoint of the drug (used to be thought of as exclusively apoAI/HDL modulator), the idea that apabetalone synergizes with rosuvastatin but not atorvastatin (supported by post-hoc SUSTAIN/ASSURE), the apoAI/HDL response being modest and primarily occuring in low-HDL patients, the fact that the mechanism of action/target was't appreciated until Phase 2 stage, the transient liver aminotransferase elevations, the failure of CETP inhibitors to support the HDL hypothesis, etc, etc, etc.......and there is good reason for the FDA to not immediately approve Phase 3. Which begs the question, why did the EMA approve BETonMACE but not FDA. Perhaps EMA is more forgiving for post-hoc analyses and more willing to take a gamble on a potentially revolutionary therapy?

Anyways, I think that article that Kelsee shared was a bit harsh. There have been HUGE advances in cardiovascular and diabetes therapies in the last thirty years. These advances have extended lifespans and improved quality of life for millions of individuals. Perhaps that article was too general of criticism of the FDA and pharmaceutical industry. I'm not a believer in the conspiracy theory of the FDA/big pharma slowing the progress of Resverlogix/Apabetalone. 

Coldnewfie stated "I just don't understand why posters would think that the Betonmace trial would be altered because the FDA have approved it.  It is late but to change the FA to something other then the original goal of 125 events now just doesnt seem reasonable. ???"

I suggest you look at the most recent MD&A and the news release from a couple months ago announcing FDA approval to include US patients. "Resverlogix has agreed to make adjustments to the existing BETonMACE study protocol." "A futility analysis is planned after 50–75% of the primary MACE events have been adjudicated." That is why we think BETonMACE trial design and futility analysis timing may be altered.

BearDownAZ