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Biotech / Medical : Isotechnika

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To: teevee who wrote (277)	5/27/2008 10:52:49 AM
From: kenhott	of 285

Since I opened my big mouth re: the interim 2b PR back when... Most docs would take great care to not screw up with a rejection drug. Prograf is proven. To get it wrong means someone drops a kidney or a liver or etc and that will likely be the end of that person's life. Non-inferior even if really true may not be good enough. ISA needs to beat on acute or chronic rejections. ISA's interim result showing acute rejection advantage did not hold. It was not unexpected. Not a lot of numbers in this release (especially of the high dose arm), just a lot of words. There is always chronic but not very likely to beat Prograf out right. PR shows NODM is better with low and mid drug arms vs. Prograf. Looks like high dose drug had ~ NODM numbers as Prograf. They started Prograf at .05mg/kg BID. Side effects in Prograf are mostly dose related. Most people I think would start Prograf in kidney at .02-.03 mg/kg. Maybe they ended up at the same trough but that strikes me as an issue. What will a bigger phase 3 show?

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