pax...
I like the start of the post...I don't think the Pyrr part is germane..
First off we can only speculate what is coming down at the AdCom..The FDA may not being plotting some form of revenge ...but simply doing their job and the size and importance of the drug is as JT says..Puts it in a category where an AdCom is appropriate..I think we are too scarred because of the 2013 AdCom...I was dumbstruck by what happened, but over the years I understand why FDA did what it did...because of a mistake (a huge mistake) FDA made in awarding an SPA for a CVD drug which had no CVOT...
There is not going to be an issue like that in this AdCOM..The FDA is going to have to walk past four caskets to deny Vascepa...Those would be the AHA, the ADA, ICER, and Canada...In this AdCom we have what we need..Which is the R-I results and the support of the medical authorities and believe me..Pyrr is not going to impress them..
":>) JL