RE:RE:RE:What risks might their be to NASH trial failing?I would go to the Dec2018 fda guidance doc (that's still in the discussion phase)
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM627376.pdf and look at the first paragraph in III General Considerations
"
Splitting NAFLD into three successive stages (NAFL, noncirrhotic NASH, and NASH with cirrhosis) can provide sponsors a convenient conceptual framework to identify areas of potential future drug development. At this time, because patients’ NAFL can exist for many years and may not progress to NASH, it may be challenging to demonstrate a favorable benefit-risk profile of pharmacological treatment(s) in NAFL patients. Therefore, NAFL treatment may be better addressed by interventions such as diet and exercise. " I would put liver fat ALONE into this early stage of disease progression. So alone the FDA sees it as "challenging to develop pharma treatments for this stage of the disease. I'll be looking for outcomes along the lines of Intercept's either NASH resolution or fibrosis reduction for the results to be exciting, hopefully better than Intercept's
SPCEO1 wrote: It is not much but perhaps one of our more science minded freinds will comment on it if there is anything worth saying about it.
stockman75 wrote: sounds good. No idea what it really means!