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dewophile

09/25/16 6:57 PM

#204596 RE: iwfal #204589

I'm on mobile so will be brief. In general I think there's every reason to pay attention to liver se. Not only in light of prior hold for first fgen agent but also the moa which probably relies on liver for epo production. The randomized trial of one case of lft excursion in a drinker really doesn't bug me. The fact there were no liver elevation among 29 placebo pts in the study that you pointed out in prior email also doesn't bother me. Fact is there was no drug related liver tox in the study by any reasonable measure. The second case is off putting it clearly happened after Roca dosing and one shouldn't have to work to figure this out. I expect better from this management team. That said I think liver tox is a relatively low risk for the program at this juncture but it's still a risk (and will be even in early stages of launch if its a one in ten thousand deal).