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Replies to #3315 on Biotech Values
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DewDiligence

08/25/04 9:07 PM

#3316 RE: drbio45 #3315

>> it says only one of the eyetech dose levels reached statistical significance but it looks like the .3 and the 1mg dose did… One of the two trials for the 1 mg dose demonstrated statistical significance (p=.0273 and p=.0035) <<

When a clinical trial tests multiple doses, the p-value threshold for statistical significance is reduced accordingly. Since EYET was testing three doses, statistical significance was defined as p<.0167 (i.e. .05/3). By this definition, the 1mg dose failed on one of the two trials.


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zebra4o1

08/25/04 9:19 PM

#3318 RE: drbio45 #3315

Good point about the reported p-values being less than 0.05. - not sure what is going there. In the FDA briefing material, p values of 0.02 and below are highlighted in yellow, while p = 0.03 or higher are not highlighted.

Kind of sad looking at the trial results graphs which show that all this treatment does is slow down the progression of the disease. It doesn't stop vision loss or improve vision. Not saying it shouldn't be approved, but this definately isn't a silver bullet.