AGIX and Liver failure in ARISE - the issue is the concurrency of the bilirubin and the ALT elevations. Hy's law (which is the basis to most of the FDA judgements on liver tox) says to expect approximately 1/10th of that rate (or more) as deaths or complete liver failure requiring transplant. Sadly AGIX management appears to be putting their head in the sand. In the Quarterly CC of several weeks ago they were asked a question as to whether the bilirubin and ALT elevations were concurrent. And they answered:
"The typical standard is to look at confirmed elevations of LFTs and also look and bilirubin changes and we didn't see any confirmed LFT changes along with bilirubin changes in either of the two study groups, either the placebo patients or the 1067 patients."
I.e. they didn't answer. "Confirmed" in this case probably means "persistent". Hy's law (and therefore the FDA) does not care about 'persistence', only concurrence. If Rob Scott hadn't bought a bunch of shares I'd say this and talking about filing in 12 months after running a short glucose control trial was just a way to get the price up some to avoid excess dilution. But Rob Scott did buy a bunch of shares - so I suspect this is more about another episode of Rob Scott ignorance (e.g. his ignorance that the blended overall KM curves of 1 yr ago vs PROVE_IT and IDEAL were meaningless for assessing the likelihood of ARISE success in a post Drug Eluting Stent world. Or his claim in the last Q CC that 1067 would be the first diabetes drug to have efficacy in heart hard endpoints - when Actos showed something very similar.)
Altogether I think Atherogenics has a workable drug in both heart disease and diabetes - but will only get regulatory approval for hard endpoint kinds of data to PROVE a benefit that outweighs the drawback of liver issues. And Atherogenics management doesn't appear to want to go that route due to time and expense.
FWIW.
Clark
Market Data 
Markets 
AI
