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!