| | 'Interesting new look at the CHF trial. Keep in mind that, although this looks like a somewhat promising result on the surface, you have to look at how they arrived at it.
What they are doing is called data mining. They are looking through the various subgroups of a trial that failed to meet the primary endpoint. If you have a good knowledge of statistics, you will understand why this is a questionable technique, and why the FDA very seldom accepts this kind of analysis. If you look hard enough, you will usually be able to find some group in a trial that has 'good' results. The number of possible subgroups is huge (male/female, young/old, very ill/less ill, smokers/nonsmokers, the list is almost endless). The likelihood is very high that by random chance, there will be some subgroup that shows a 'positive' result. If you do not understand this, you don't have a good appreciation of what VAS is doing here.
Now, in this case, the fact that the Class 2 patients, and the Class 3/4 patients who have not suffered a heart attack, both show significant improvement lends some creedence to the analysis VAS is doing. The scientific basis they are postulating makes sense. They may in fact have found something which is real. A confirmatory trial would reveal whether they are looking at a statistical abberation, or a replicable effect.'
Excerpt from: messages.finance.yahoo.com |
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