Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: BulbaMan who wrote (9188)	9/23/2003 12:48:18 PM
From: Biomaven	Read Replies (1) \| Respond to of 52153

I've taken a very brief look at the Memantine docket available at the FDA site: fda.gov Looks pretty solid. although there are the usual FDA grumbles (like a subgroup analysis on the most severe patients indicates they were not helped much by the drug, and grumbles about the quality of the Latvian study). The statistical review usually has some opportunity for a smile, and this one is no exception: There were 11 patients in center 013 (6 placebo and 5 memantine). The average change for placebo patients in this center was -11.33 compared to -0.60 for memantine patients. The difference in treatment group mean changes (+10.73 ± 3.77 S.E.) in this center was considerably larger than the average (+1.34). This center?s results are somewhat atypical and if we discard this center from the ITT population we find that the treatment effect on the change in ADL adjusted for baseline and center is no longer significant (p=0.0766). The difference in group mean changes drops from 1.34 to 1.05. On the other hand, center 003 had 14 patients and a large negative difference (-6.57), so exclusion of this center would increase the significance of the treatment effect. Nonetheless, the fact that the removal of center 013 can alter the conclusions calls the strength of this evidence into question. This is as bad as subgroup analysis. I'd guess that in most studies you could find some center (or other subgroup) where ignoring it kills the statistical significance. But it looks like overall some of the p values in the study were so strong that no matter which way the FDA and statisticians twisted things they couldn't "achieve" non-significance. Peter