Biotech Values

[dewophile]

FGEN

I understand it's tough to handicap a large trial like this w many variables. Given this is essentially a safety trial it's fair to say the longer it goes the greater the odds of success, and i guess we can leave it at that. Overall event rates are high (even in non-dialysis where i found it to be in the 5% range), so if half of patients have already been enrolled with a critical mass getting close to 6 months exposure and no imbalance goign the wrong way i would get more comfortable..

And what, pray tell, are the places you'd expect greater 'safety' for Roxa? (-g-). (I am amused that there is a giant elephant in the room that no one mentions directly. And I am no different - but I'll at least open the dialog now.)

you answered your own question so i don't have much to add. I agree MACE is the most significant, and based on what we know i would think this could go in favor of roxa more than the other way around. Better correction of anemia can lower CHF, which is perhaps the single largest SAE noted in trials. If erythropoetin is linked to MACE directly then obviously that can favor roxa. Same goes for excursions above targeted HGB. HTN too looks like it should be lower w roxa. The improvement in lipids is likely something that won't affect MACE early on.

another major cause of death in CKD is infection and decreasing hepcidin may increase infection rate

good point