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Biotech / Medical : IPIC

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Aug 15 3:35 PM EST

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To: WeirdPro Randy who wrote (1125)	3/31/1998 4:49:00 PM
From: NeuroInvestment	Read Replies (2) of 1359

Re: <<Does the study decrease potential liability for the patients that may show damage from the version that was marketed?>> The study had three groups; 1) Redux II, the once-daily formulation; 2) Redux I, which was the marketed version, and 3)placebo. Thus the results are directly pertinent to the marketed version, because there was no statistically significant difference between that group and placebo. This pretty much blows the oft-stated "fifteenfold" association between Redux and valvulopathy out of the water. However, it does not entirely put the valvulopathy question to rest. The fact that all trends were towards higher incidence of valve anomalies in the Redux groups than placebo, even though not reaching p=.05 (and I look forward to finding out what the p values were), keeps alive the question of a small effect...and again the duration issue is pertinent. If they do any analyses of this data stratified for length of use, it will be interesting to see if one starts to see significance with longer duration. While only 4% of Redux patients took it for more than six months, this study does not rule out duration based changes, since it did not include anything more than 4 month usage. This study provides great support for the hypothesis that I have written about at length; there is no hidden iceberg of widespread cardiac disease about to emerge to sink Interneuron. Whether there will be a very small subset of patients who may yet show signs of valve changes (and might still pursue legal action, irregardless of the absence of 'absolute liability' for pharmaceutical companies) is still yet to be determined. It is a very good day for Interneuron, but it is not yet the end of story. NeuroInvestment (www.neuroinv.com)

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