I mean, why weren't they prepared to defeat this line of reasoning by the FDA (and adcomm members). Did they just think everyone would say, YES! Don't want to hear any explanations, just YES!
The two biggest questions were being thrown around since the FDA released the documents for the conference.... possible placebo problem and what about lack of data for specific indication? I guess they should have prepared arguments for the other more minor concerns, but how were they NOT READY FOR SOMEONE TO SUGGEST THAT THEY HAVE TO WAIT FOR REDUCE-IT????
its really effed up in my opinion. it basically came down to the fact that the prevailing science on lower triglycerides positively affecting CVD risk has changed over the course of the trial. but you know how it is... in a few years they are gonna say.... oh wait a second! it actusly doessss help..
That sucks. My doctor always tell me that high TG level will increase my CV risk and I truely believed that. Now, I can tell my doctor, "Ya, ya, you are tricking me. "
If current science has proven there is no such relations, what is point to continue REDUCE IT trial. It will just waste money. What will fda say if two months later, another what so-called science study says: "we have found out that lowering TG does help lowering CV risks and save life...."