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Re: iwfal post# 204576

Saturday, 09/24/2016 10:14:14 AM

Saturday, September 24, 2016 10:14:14 AM

Post# of 251793
FGEN/AKBA -

But they haven't had *any* LFT issues in the placebo arms of the reported Roxa or AKBA NDD HIF RCT trials. Which, combined with the fact that they had explicit issue in the earlier drug, is my point. E.g. there was also a withdrawl from 017 in treated for liver disfunction. An alcoholic, but nonetheless the point stands that we don't have a good placebo base - but the one we have says liver excursions don't happen often in this population.

Do you have a link to the specific LFT issues you're referring to? I'm not doubting you at all; I'd just like to see the magnitude of what you're referring to.

It wouldn't completely surprise me. But OTOH I think unless it is very common (unlikely) it is unlikely to jeopardize the EPO resistant indications.

I like to think about things in terms of worst-case scenario. Not entirely worst-case scenario obviously (worst-case would be no role for roxa in any pop), but if roxa only has a role in just the EPO-resistant indications, I think that would be meaningful enough for the company (and support valuation).

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