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Biotech / Medical : AtheroGenics, Inc.{AGIX}-nasdaq -- Ignore unavailable to you. Want to Upgrade?


To: Clarksterh who wrote (306)10/21/2007 12:02:16 PM
From: mlrb2113  Respond to of 332
 
<<Dr. Fleming is President and Chief Executive Officer of Kinexum LLC, a prominent life sciences consulting firm.

The use of the present tense is odd. Is he not leaving his old job?>>

I didn't notice that, but it strengthens my first impression that AGIX hired him as a consultant (in desperation?) to try to save 1067 from the liver tox issue and possibly other potential problems. I don't think Rob would've left voluntarily or been forced out after all his years there if things looked rosy.



To: Clarksterh who wrote (306)10/25/2007 11:28:43 AM
From: keokalani'nui  Read Replies (1) | Respond to of 332
 
Draft Guidance for Industry on Drug Induced Liver Injury:

fda.gov

Excerpt:

In general, the type of liver injury that leads to severe DILI is a predominantly hepatocellular injury. Hepatocellular injury is indicated by rises in serum AT activities reflecting release of alanine or aspartate aminotransferase (ALT or AST) from injured liver cells. The ability to cause some hepatocellular injury, however, is not a reliable predictor of a drug’s potential for severe DILI. Many drugs that cause transient rises in serum AT activity do not cause progressive or severe DILI, even if drug administration is continued. It is only those drugs that cause hepatocellular injury extensive enough to affect the liver’s functional ability to clear bilirubin from the plasma or to synthesize prothrombin and other coagulation factors that cause severe DILI. It is important to identify those drugs as rapidly as possible.