Biotech Values

[iwfal]

AGIX - The liver tox issue is WAY overblown in my opinion (although I still have a few questions about the different definitions of liver failure).

a) Rosuvastatin had 2 cases of "jaundice" in 12,000 patient years in their approval trials. 1 per 6000 patient years. And that was largely on 10mg while current SoC is higher dosages. Assuming "Jaundice" is similar to "Recoverable Liver Failure" seen in ARISE then this actually looks like a background rate in a population taking not only statins but a ton of other drugs.

b) The rate of elevated enzymes is not stat sig in ARISE AND it is well within family for statins based upon some of the FDA documentation. It is also a LOT lower than the rate seen in Rezulin.

Might there be liver problems? Yes. But in order to know it has to pop up above the background rate and there appears to be absolutely no way to conclude that from the ARISE data (assuming 'jaundice' and 'recoverable liver failure' are roughly equivalent).