Replies to post #3917 on Biotech Values

[Skeptic]

The point of my previous post is that there is a strong correlation between plaque regression and a reduction in cardiac events. Hence, there is a good chance ARISE will meet its endpoint. Also, I believe AGIX has a SPA for the ARISE trial and so, if it meets its endpoints, the FDA will most likely approve it on its own merits and NOT require a confirmatory pivotal trial.

The ARISE phase III by all accounts is a well run trial and sufficiently powered for success should AGI-1067 actually have biological activity. Here's a comment on the phase III from Needham...


"The real focal point of the valuation thesis remains the outcome of the Phase 3 ARISE trial, a well-designed
(prestigious academic centers), big (more than 4000 patients), and (potentially) pivotal trial."



One other thought - I think people are getting hung up on the point of the CART-II and what really matters to patients and the FDA - that is a reduction of cardiac events. If the AGI-1067 shows a reduction of 20% in cardiac events above and beyond statins, the FDA will approve it and consumers will buy it. There won't need to be a confirmatory trial. The point is that when the final data is analyzed, if the READABLE IVUS scans (30% not readable) from the patients that showed up for the follow up (20% didn't) show a stastically significant regression from baseline, the odds of success in ARISE are pretty darn good.

JMSO!

[Biowatch]

>>Today, Nissen says he wishes that he had not gone on the AtheroGenics conference call. He is surprised about how well AtheroGenics stock has done since, and worries that investors misunderstood him. "I didn't think people would listen to those words and say this is the best thing since sliced bread."

Topol, the clinic's top cardiologist, is even more negative on the AtheroGenics study. "You can't make anything out of these data," he says. "I'd love to see the drug work; that's not the issue. I just cannot accept their methodology."

Topol first criticized the AtheroGenics studies in Barron's. <<

http://www.forbes.com/2004/10/05/cx_mh_1005drugdata_print.html

From the same story:
>>On a conference call with analysts, Merck research chief Peter Kim said that at the end of the study, 15 people out of every 1,000 taking Vioxx had heart attacks or strokes after three years, compared with 7.5 out of every thousand taking a placebo. However, those appear to be the number of heart attacks that occurred per year.

But according to Eric Topol, chairman of cardiovascular medicine at the Cleveland Clinic, some 45, or 3.5%, of the 1,300 patients taking Vioxx in the trial had heart attacks, strokes or other cardiovascular events. About 25, or 1.9%, of those taking sugar pills had heart attacks or strokes. He says the event rates were given to him by an executive at Merck. Merck could not comment in time for deadline.

Topol was one of the first to call attention to Vioxx's potential for causing heart problems. Now he says, "Even when they're withdrawing the drug, they're spinning it." <<