SI
SI
discoversearch

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 : AtheroGenics, Inc.{AGIX}-nasdaq
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: keokalani'nui who wrote (279)6/29/2007 8:33:44 PM
From: Clarksterh  Read Replies (4) of 332
 
but is it possible, even at the ARISE dose, that liver tox is actually as rare or manageable as it is for the statins?

Statins have never been shown to have a bilirubin problem. And it is the bilirubin incidence rate that will catch the eye of the FDA (Hy's Law).

Also note that even if the lower doses of 1067 do reduce liver tox it is very clear that the new trial won't in any way show that. Too small a trial.

It is FDA approval that is at risk here (although I'll acknowledge that I lost sight of that in my last post).

PS I suspect that at the high doses of statins there is a Hy's Law issue. There is data indicating an issue. But not a lot - and the liver tox data for the really big trials of high dose statins is not accessible. E.g. If I remember correctly PFE has not ever filed for a label change to emphasize the high dose of Lipitor. Proof of anything? No, but interesting. Why run the risk of being Glaxo'd?
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  

HomeMailHotSubjectMarksPeopleMarksKeepersSettings
Terms Of UseContact UsCopyright/IP PolicyPrivacy PolicyAbout UsFAQAdvertise on SI
© 2025 Knight Sac Media.  Data provided by Twelve Data, Alpha Vantage, and CityFALCON News