Biotech Values

[dewophile]

ENTA

It was not entirely clear from the FDA warning that these events occurred exclusively in patients with decompensated cirrhosis - to the contrary the warning suggested that at least some of these SAEs were in pts with compensated cirrhosis:

http://www.fda.gov/Drugs/DrugSafety/ucm468634.htm

Our review of adverse events reported to the FDA Adverse Event Reporting System (FAERS) database and to the manufacturer of these medicines, AbbVie, identified cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines. Some of these events resulted in liver transplantation or death. These serious outcomes were reported mostly (i.e. not exclusively) in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with it..

If indeed pretty much only decompensated cirrhotics are affected, as suggested by the ABBV PR, then i agree w you totally