Toinv, further to our discussion on the other board... I know there is a far bit of criticism of the FDA, but I don't find it helpful in my DD to assume lack of FDA approval is a conspiracy between the FDA and big pharma. After all, RVX doesn't seem to have had trouble with FDA approval for any prior study.

I have to assume RVX has done substantial back and forth with the FDA to try to satisfy the requirements for Phase III. Other than the issues I mentioned (MACE 5 vs 3, the inherent problems with any post hoc study), the article below makes me think a larger sample size (or the perhaps the adaptive aspect) might be subjects of negotiation.

Perhaps given the multiple Phase II primary outcome failures, the FDA would prefer another Phase II. Hard to know. Perhaps they will still work it out with the FDA, but given the trial has been defined (clinicaltrials.gov) and has already started, I don't know how they could now change the study much if required.

Yale Study On FDA Approvals -- Informative Or Irresponsible?
John LaMattina, Forbes
Feb 11, 2014

http://www.forbes.com/sites/johnlamattina/2014/02/11/yale-study-on-fda-approvals-informative-or-irresponsible/