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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (9430)	11/6/2003 6:57:07 PM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 52153

Peter, I am sure that your friend cardiologist is more qualified than I to talk about medical value of the observed results. As I said it is my layman concern about how trial is done and what one can speculate (or conclude, whatever) from it. Randomization and groups baseline balance was compromised. Randomization is done AFTER baseline IVUS (and laboratory measurements). They chose arteries that are not more than 50% occluded, and Pts with recent ASC but otherwise stable diseases. Target was 2% reduction in 15 mg and 4% reduction in 45 mg (absolute reduction). The main (and very important here) difference between 15 mg and other groups (pl and 45 mg) is LDL & HDL baseline level (as well LDL/HDL ration), atheroma volume and max plague tickenes. This difference is somewhere +25%. WHY! WHO DANE RANDOMIZATION AND BY WHAT CRITERIA? << Agreed that the patients in the trial did not have particularly low HDL - I would assume you would see even more benefit if you selected for patients with low HDL.>> Interesting the Italian village subjects have HDL level at 10-30 mg/dl while 15 mg group had average 38 mg/dl (pl. had 46mg/dl, and 45 mg group had 45 mg/dl). If you want you can write other laboratory parameters. So, they did selected Pts in 15mg group with relative low HDL level, but total cholesterol is in normal range (<200 mg/ml). Triglycerides level were also relative low in 15 mg (and 45 mg) group. Also I will mentioned here that cardiologist separate Pts based on HDL level (>40 mg/dl, and <40 mg/dl as high risk), and for LDL separation value is ~160 mg/dl. Second interesting point is that investigators (authors) did not reported laboratory measurements (HDL and LDL level) after treatment. WHY? IF I work as JAMA editor I will ask for this data before even thinking to accept publication. IF ApoA-IM work buy reverse cholesterol transport (from artery to liver, rise in HDL level? maybe decrease in LDL???) this should be reflected in HDL/LDL ration and blood levels after treatment. Where are data??? At this point I will be surprise if PFE pick up candidate, but maybe we do not have ALL relevant data. Miljenko [eom]