Biotech Values

[mcbio]

FGEN/AKBA -

appreciate all the comments. I just want to point out that FGEN may not be as egregious as you suggest in the liver tox department. It would be naive to think there were zero LFT abnormalities in ph 2 since placebos have LFT abnormalities. The rate of LFT abnormalities was more or less in line w placebo so therefore I don't think it is egregious (or even inconsistent as you say) to state they had no liver enzyme safety signal. The FDA also isn't requiring heightened surveillance on this front either fwiw

that said i do think some idiosyncratic SAE like a liver failure remains a risk to the program (along w some link w CA, etc.)

on cardiac i tend to think fgen may prove better than epo - although your concern about the temporal nature of events is duly noted

Would like to think that the numerous DSMB hurdles roxa has cleared and accumulation of patient years on the drug would give some degree of comfort for roxa on the safety front. Doesn't guarantee anything at all of course, but hopefully some degree of comfort. Much more so than the AKBA drug I would think.