Murphy...
Please understand, I'm not 100% convinced the trial will halt in the next couple of months. It will not be a shock to my system if the decision is to continue, the way Adcom was.
I'm estimating the chance the of a halt being around 70% which means I believe there is a greater chance the trial will be halted on the interim data than not..This based on historical trials, the scientific evidence in the literature and population studies..My uncertainty arises from the trial design in which eg. There is an arbitrary definition for what does and does not constitute a MI (heart attack)..To be specific, In the primary outcomes if a patient has an MI as diagnosed by EKG, blood chemistries, or dye studies,or any other method; and the patient dies within 30 days of the triggering event...The event is not listed in the primary outcomes as an MI, it is listed as a CVD death..
This raises the possibility if EPA improves survival after an MI compared to placebo, because the patients on V survive the MI, their events are designated as MIs (heart attacks) where as more placebo patients die...and therefore are not listed as heart attacks, but as CVD deaths...Then there could be an under reporting of heart attacks in the placebo group and a relative over reporting in the V group which makes it look like V does not cut the incidence of MIs..
Still I do not see the CEO making the statements you claim..Sorry I'm not buying it...I'l wait for the press release..Your credibility to me is pretty low..
":>) JL