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Sunday, February 06, 2011 12:55:08 PM
Yes, I remember that less than convincing response from the CTSO CEO. What did you expect him to say? The interesting thing is he is arguing that the device will not be as effective because you need to use it before admission to the ICU. BUT, what he may have missed is that this paper, demonstrating efficacy of the Toray device, published in JAMA sowed the effectiveness of the device when used in the ICU. Here is the phrase from the JAMA paper: "Hemoperfusion was performed
in the ICU". That seems to blow away Chan's response. Also, there are papers demonstrating that this device not only deals with endotoxin, but cytokines as well:http://www.ncbi.nlm.nih.gov/pubmed/20473253
Finally your last comment missed my point, which was that it is impossible to draw conclusions from this study in that it is not a head to head comparison of the CTSO device and Toray's. I think you are relatively new to the pharmaceutical industry so you statement that p values alone will be convincing. Docs will look at the size of the study, the open label design etc and they will form their own conclusions. In my opinion, they will be interested but will demand and expect larger more well controlled studies before they widely adopt.
in the ICU". That seems to blow away Chan's response. Also, there are papers demonstrating that this device not only deals with endotoxin, but cytokines as well:http://www.ncbi.nlm.nih.gov/pubmed/20473253
Finally your last comment missed my point, which was that it is impossible to draw conclusions from this study in that it is not a head to head comparison of the CTSO device and Toray's. I think you are relatively new to the pharmaceutical industry so you statement that p values alone will be convincing. Docs will look at the size of the study, the open label design etc and they will form their own conclusions. In my opinion, they will be interested but will demand and expect larger more well controlled studies before they widely adopt.
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