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Biotech / Medical : Biotech Valuation

CRSP 56.61

-0.6%

3:59 PM EST

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To: Biomaven who wrote (50578)	12/31/2018 4:08:16 PM
From: tuck	Read Replies (1) of 52153

OK, so it appears the bear case is like this: There's apparently evidence that increased hematocrit form administration of ESAs contributes to MACE. Vadadustat (from Akebia) produced a pretty much dose dependent increase in hematocrit. Roxadustat is in the same class, and if it's a class effect, the risk of the same hematocrit rise exists. Here's a link to the supplementary data from Akebia's P2 showing the hematocrit values: Vadadustat Hematocrit Surf to the fourth of five figures. In rats, Roxadustat apparently didn't produce a signal until about 10x the dose being used in humans. Dosing difference, drug difference, or missing data with black swan potential? I'm not aware of FGEN publishing any hematocrit data from their human trials. Cheers, Tuck

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