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Biotech / Medical : Biotech Valuation

CRSP 55.15

+2.5%

3:59 PM EST

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To: hmpa who wrote (4601)	9/7/2001 10:51:04 AM
From: Biomaven	of 52153

<<MATX>> The briefing documents are available: fda.gov A quick scan reveals a pretty hostile FDA review - grumbles about dosing errors and serious disputes about the number of responses. The following paragraph is interesting: Even more significant, FDA statistical analysis (Table 14 in FDA statistical review) suggests that the results in favor of CEG on preventive goals are artifacts of bias. Patients on the placebo arm dropped out of the study earlier (probably due to progression or lack of response) and therefore were not on study for the requisite 28 days to be declared a "success." The analysis was not driven by actual failures (e.g., skin breakthough) on the placebo arm, but rather by the tendency for patients on the placebo arm to drop out sooner. (Actually, 4 patients on CEG and 0 patients on placebo failed by having the event that was to be prevented). One should also consider the effect of these data on the sponsor's analyses of the correlation between clinical benefit and objective response. These preventive data should be excluded from such analyses. If the patients were dropping out of the active arm, you better believe that the FDA would be counting them as failures in any analysis. Note that I've never followed the company and I've only just glanced at the briefing document, so my comments are not well-informed here. Peter

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