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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


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