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Biotech / Medical : Pharmos (PARS)

PARS 2.700

+13.6%

Jan 21 4:00 PM EST

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To: marin who wrote (1278)	10/19/2004 8:06:43 PM
From: Clarksterh	of 1386

jonmarin - The new covariate analysis will hopefully show a stronger statistical difference between dex and placebo. Agree completely that the overall p will be better than it would without covariate analysis. My point was really almost a pedantic one - that by doing the covariate analysis, there is a chance that one subgroup (out of n) will not show adequate (however that might be defined in the much smaller subgroup) improvement correlation with DEX. And thus be left off of the label. The problem with interim analyses is that you may get a difference that looks significant, but when the trial runs to completion it turns out to be a random fluctuation. Much like tossing 6 heads in a row. Agree again. Hence the statistical penalty for interim looks. Hoping to understand the penalties better at some point. As far as subgroups showing efficacy, if the primary endpoint isn't reached imo the share price will drop regardless of what subgroups may be stat sig. Agree completely and absolutely! The problem with subgroups is that some may be appear significant by chance. Yup, another need for statistical penalty! One general paper on single study trials mentioned that the p value should be .00125 or less. to equal two stat sig trials with a p value of .05. The odd thing about that is I have seen lots of single phase III trials with p<0.05 where the NDA was approved by the FDA. I know the FDA likes at least 2 Phase III's but that desire seems to be violated on a routine basis. And I don't understand why or when the FDA finds this acceptable. ?? If you want a history of PARS it might be useful to read through all of the commentary on PARS on the neuroinvestment website Thanks! Read them over the weekend and subscribed today. Clark

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