"That’s interesting because I think this is one of the most likely outcomes from ARISE. An important question for investors is whether AGI-1067 will still be approvable if this occurs."
The reason I said that is I believe there have been studies showing a strong correlation between the halting of progression and or regression and the number of cardiac events. I would think if AGI-1067 is truly reducing plaque, a statistically significant decrease in cardiac events is a slam dunk. They only need a 20% reduction in events from ARISE to be successful. (I believe they have a SPA)
I'm still torn here - Birchenough from Lehman, who's made some good calls, upped his target to 50 bucks and he placed high odds on the success of ARISE. However, I like Monane at Needham as well and he's neutral on it because of the valuation.
If it reacts badly to the Barron's article, I might buy a few Jan calls. If the remaining scans confirm the original, a partnership should be inevitable. And if OSCAR is good, that will help too.
One other thing - I saw a number of your post on Yahoo and I thought I would leave you with this thought from the Lehman report. I'm not sure the thrown-out data is a big deal...
"Interim Analysis is Appropriate
While there have been some questions regarding the impetus for conducting an interim analysis and the inclusion of the
Cleveland Clinic as a third party reviewer we believe that the conduct of this trial is beyond reproach. In particular, we believe
that both investigators, Dr. Tardif and Dr. Nissen, still remain blinded to which patients received drug and that the true impetus
for including the Cleveland Clinic as a third party reviewer was the emergence of technical issues with certain scans that
precluded accurate analysis of the study. While AGIX has not provided extensive detail on the exact timelines of events that
generated the need for the inclusion of the Cleveland Clinic we believe that it was likely that a higher preponderance overall of
technically inadequate scans prompted the need for an independent third party to exclude scans that could not reasonably be
interpreted. Technically inadequate scans typically arise from insufficient length of diseased vessel, calcifications of the
vessel which interfere with the IVUS signal and tortuous twisting vessels that cause too much rotation of the IVUS catheter
that in turn impacts IVUS signal quality. In the REVERSAL study roughly 7-8% of such technically inadequate scans were
removed and the explanation of a much higher rate, closer to 30%, likely provided reasonable impetus for an independent
review. We would remind investors that while typical IVUS atherosclerosis trials like REVERSAL exclude these patients at
the outset of a trial the CART-II trial was initially designed as a restenosis trial where calcifications and vessel tortuosity are
less of a concern. As such, we believe that the explanation provided by AGIX and its investigators for the involvement of the
Cleveland Clinic is highly credible and that the rationale of removing patients with technically inadequate scans has strong
precedent and was conducted in an appropriate manner in this instance. Ultimately the supportive statements of both Dr.
Nissen and Dr. Tardif and their expressed interest in submitting this data for publication in a high caliber journal speak to the
rigor of the underlying data collection process and overall trial conduct."
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