20% reduction over and above statins doesn't seem like a trivial target either. Will 4,000 patients be enough to reach significance?
Certainly arise isn't without risk.
I also wonder about the 450 odd patients they followed in cart II. Surely they must have some sort of data on their events and outcomes over their 12 months of therapy?
I missed my opportunity to pick up some calls when AGIX dipped to 28ish this morning. Interesting that the stock finished up over 4% after that Barron's article. Maybe shorts are getting out or maybe Lehman is right.
Here's more relevant comments from Lehman (emphasis mine)...
"Positive Plaque Volume Benefit Likely to Predict Phase III Success While we have recently argued that plaque volume burden is not the only determinant of ultimate coronary events and that CART-II disappointment would not be predictive of ARISE phase III failure we do believe that the positive predictive value of IVUS studies has been well established. With a high degree of confidence in the final CART-II trial outcome and several outcomes studies like PROVEIT demonstrating a clear link between plaque volume benefit and coronary event reduction we believe that the phase III ARISE study for AGIX is very well handicapped to succeed. Indeed, with several regression studies like FATS (mevacor) and HATS (pravachol) suggesting reductions in coronary events in excess of 70% with smaller plaque volume reductions than seen here in CART-II we believe that AGI-1067 will have no problem in demonstrating a greater than 20% reduction in coronary events in the ARISE study later next year. To the extent that the benefit of AGI-1067 may extend beyond plaque volume reduction and actual improvement in endothelial function and plaque stability we believe the odds of success are all the better."