Biotech Values

[AlpineBV_Miller]

So it is reasonable to ask what real predictive value IVUS provides in translating phase 2 data to phase 3 mortality data.

There is no evidence CETP inhibition works except by raising HDL, which it does by preventing HDL from offloading (not exactly a sound approach). Any CETPi Phase II program has to, at a minimum, provide you a reason to go forward AND some guidance as to how to design and power the trial. The Phase II trial run does neither.

So what if a mobidity/mortality/RLT/IVUS study costs a lot and takes a long time? Better to do that then waste hundreds of millions on a Phase III that will duplicate the failures of the JTT and PFE drugs.

Peter, you're right lipid stool endpoints are not validated. But if you are designing a drug to effect RLT, you'd better have some data somewhere that lipids are being transported out of the body. Stool studies give you at least that.