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Re: iwfal post# 204571

Friday, 09/23/2016 10:44:41 PM

Friday, September 23, 2016 10:44:41 PM

Post# of 251604
FGEN

I missed the twitter exchange (I still can't find any of jq1234t's tweets - following a twitter thread is painful IMO)

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

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