Biotech Values

[dewophile]

The bilirubin, the spike in ALT on first dose, and even the quick liver tox in the alcoholic

Here is where faith in the management team matters some. If the bilirubin elevation were tied to LFT elevation that would be a very big deal. If someone had cholestasis or some other explanation for a transient elevation in bili then not as big a deal. The fact they state no case met Hy's law, the fact the FDA didn't require heightened liver surveillance in ph 3, and the fact a few thousand pts have gotten the drug now provides some confidence this case of elevated bili falls more in the benign realm. ditto on the LFT in the drinker - i can easily see a pt abstaining to get into a trial and LFTs can rise pretty quickly after hitting the sauce again. If they weren't as far along in ph 3 i would have more concern re safety given this flag you raise

Further there is data that Fibrogen hasn't actually published, so far as I can tell: they appear to have run a special trial just to determine how the drug worked in those with moderate liver impairment ( https://clinicaltrials.gov/ct2/show/NCT02161224?term=roxadustat&rank=11&submit_fld_opt= ). Perhaps nothing of importance happened, but given their behavior it is reasonable, IMO, to wonder.

yes but there is also data the FDA had prior to ph 3 that is still unpublished and the FDA doesn't seem concerned about liver tox unless the company is flat out lying about liver monitoring requirements in the ongoing studies

all companies have character flaws..But it does go into the decision mix for me.

for me too, and I appreciate the critique - you've successfully managed to crack my confidence in management some