Pharmos (PARS) Message Board

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Biotech / Medical : Pharmos (PARS)

PARS 2.700

+13.6%

Jan 21 4:00 PM EST

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To: Clarksterh who wrote (1283)	10/23/2004 3:28:19 PM
From: marin	Read Replies (1) of 1386

Re: CABG I remember trying to find statistics regarding mental cognition after CABG and other surgeries and never had much luck. I chalked it up to the newness of the field and the fact that there really isn't any way to treat the problem. Hopefully dex will show some benefit. I asked my parents and other older adults if they had heard any stories about mental declines after CABG. They had plenty of anecdotal evidence. The most common complaint was that the possibility was glossed over which led to quite a shock when the side effects were more severe than anticipated. Re: One trial I snagged the below message from another message board. It appears that Russell Katz has weighed in on the one trial vs two issue. It appears that PARS meets his criteria. Now dex just has to work at a low enough p value. >>> The agency has developed a document that addresses the circumstances under which one trial might be sufficient to establish effectiveness. It would have to be a large trial that establishes an effect on mortality or very serious morbidity. What would be the characteristics of such a trial? There would have to be an internal replication in a single multicenter trial:many centers showing significance of treatment, perhaps several of them showing statistical significance on their own. The trial might show that there were multiple subgroups of patients within the study that had a similar result.There would be very low p values, suggesting that the trial was not positive by chance. Perhaps there would be multiple outcomes, all showing statistical significance. Also, one might have a trial that could not or should not be repeated on ethical grounds.>>>>>> jonmarin

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