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


To: IRWIN JAMES FRANKEL who wrote (23720)5/21/2007 5:47:55 PM
From: DewDiligence_on_SI  Respond to of 52153
 
Reported p-values in meta-analyses ought not to be taken too seriously for the reasons you mention.



To: IRWIN JAMES FRANKEL who wrote (23720)5/24/2007 12:14:50 AM
From: Clarksterh  Respond to of 52153
 
With an n > 27,000 they did not establish by statistical significance an increased risk of death, P=0.06

Diabetes trials are typically very short. And N=27,000 isn't actually excessively big for CAD trials - especially those who haven't already had a heart problem. See for example the torcetrabip(sp?) trial which was going to last for years and planned an enrollment in the 15-25 thousand class.

Yeah, if you look at 27,000 people with no previous history of heart disease for 3 months only a very small percentage will have an MI. Even if they were all diabetics. But it is still a killer of 100's of thousands per year - because it is so pervasive.

So a 50% increase in that death rate is a reasonably big deal.

What is more interesting is that this is a drug that is supposed to treat diabetes - and one of the most important issues with diabetes is circulation issues. If it is not treating an important class of heart circulation one has to ask what effect (or lack thereof) it is having on other circulation issues - diabetes hard endpoints.

All that said, I don't have the article, nor am I familiar with meta-analysis techniques, so I can't comment on the accuracy of the analysis - but my point is that if it is true it is of importance.