cityslicker99 - My read was that the FDA was correct in saying “expedited development and review”  because it leaves so many more doors open. If they did expedited developement only it would suggest the allowing of cutting corners. There is already an expedited review process in place for drugs being developed to treat rarer diseases so that part is nothin new. 

So how could these thoughts be put in place regarding BETonMACE and RVX and the plan going forward. 

1st if RVX has applied for and recieved approval to market apabetalone for a specific narrow market that could be the best scenario we could potentially recieve. The likelyhood of that unfolding, in my mind is petty slim as the KOLs stated right after the presentation was made at the AHA conference.

2nd if RVX were to do a bolt-on-trial wouldn't they need to use the exact same parameters for any extention of the trial to have the data assimilate correctly. That would mean that stoke would still be left in and CHF would be left out. So instead of this option being the a great alturnative it could become the worst. If we got 18%RRR in BETonMACE that fell short of statistical significants, how many patients for long would it take to get to the point of that 18% becoming statistically significant?

And then the wording of  “expedited development and review” comes into play. If a new P3 trial was done under terms of “expedited development and review” then you could see the FDA looking for something within a trial that focused more on heart attack, cardiovacular death and CHF focusing more on patients that were diabetic, had an eGFR in the 30 range, were stabalized on crestor or lipitor, also stabalized on an SGLT2i or DPP4i and then apabetalone or a placebo. In this situation if the results were similar to what was experienced in BETonMACE then it would be totally reasonable for the the trial to be halted "early" for ethical reasons and to have thoughs results reviewed on an expedited basis because a 57%RRR would be an exceptional mark to reach in say...half the time it would otherwise take. In this situation it could actually be 50% more cost effective than by doing a Bolt-On.

For these reasons I think that the FDA got their wording correct in saying  “expedited development and review”

tada