Replies to post #86803 on Biotech Values

[poorgradstudent]

>Morbidity and mortality are the proper endpoints.<

hahah ok... the circle is complete!

So we're back to the point that you basically want a phase III trial instead of a phase II, or you want an underpowered trial to measure mortality / morbidity to determine if you should measure mortality / morbidity in an appropriately powered trial.

I think it is a safe bet that they have the morbidity / mortality data from the phase II trial that they ran. They simply didn't publish it for us to see.

Anyways, colour me confused yet ambivalent at this point.

[biomaven0]

Measuring HDL/LDL for a CETP inhibitor is not useful for determining power and setting up trial design, which is the whole point of a Phase II program. Morbidity and mortality are the proper endpoints.

I'm with PGS on this one. You are asking for the (by far) largest, longest and most expensive Phase II ever. 20,000 patient-years maybe? (And more if you have multiple doses).

Peter