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Re: DewDiligence post# 72626

Tuesday, 02/03/2009 11:49:58 AM

Tuesday, February 03, 2009 11:49:58 AM

Post# of 257257
I thought I was hallucinating when I saw that press release.

P value of .501!!! That would be grounds for summary judgment at trial as the chances of the results be do to something other than random chance are less than 50/50!

Then Capacity 2 comes through with a p value of .001. 1 in 1000!

Hold on here. These two clinical trials were identical except as to location of the testing centers.

What do we do. Say we have confidence in our clinical trial system but ignore the result that says that the minor improvement results seen were most likely by random chance but take the word of the clinical trial that says otherwise?

I actually liked the DNDN data better then this. At least they had multiple consistent clinical trial data.

I have no idea how the FDA handles this one. It also brings to the front how it appears to be more of a game when you try to measure small clinical benefit and dress it up with the rigor of statistics.

Tinker

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