Replies to post #189312 on Biotech Values

[DewDiligence]

Was impressed by FGEN’s 4Q14 CC. I’m referring as much to the style as the content. The style is that of a supremely confident company without sounding arrogant.

[DewDiligence]

One improper criticism of CNAT is that their phase-2 biomarker trials are too short; in fact, one of the phase-2 trials in progress is following patients for 24 months (https://www.clinicaltrials.gov/ct2/show/NCT02138253 ).

[DewDiligence]

Re: Non-invasive biomarkers of liver disease (excerpt)

The following excerpt from the journal article in #msg-112208484 warrants its own post.

Limitations of the liver biopsy:

• The liver biopsy does not efficiently reflect the fibrotic changes occurring in the entire liver because an optimally sized biopsy contains 5–11 complete portal tracts and reflects only 1/50000 the volume of the liver.

• The process of hepatic fibrosis is not linear, and biopsies from different areas have shown different stages of fibrosis.

• Several reports have shown that cirrhosis may be missed in 10–30% of patients.

• A liver biopsy cannot differentiate between early and advanced end-stage cirrhosis; thus, it cannot be used as an ideal prognostic predictor.

• Disagreements between pathologists occur, which may correlate with the experience of the pathologist.

• There is a risk of complications arising from liver biopsy, and they can vary from mild symptoms, such as mild abdominal pain, to severe hemorrhage and injury to the biliary system.

Emphasis added.