The Fatty Liver Foundation has a question for liver disease patients. The FDA has delayed a decision on Intercept's NASH drug obeticholic acid (Ocaliva) We would like to know what you think of that.
1.
Were you aware the FDA was considering Ocaliva for approval for NASH?
Yes
No
2.
Are you aware that there are no drug treatments for NASH?
Yes
No
3.
To be approved as a NASH therapy the FDA required a one stage reduction in fibrosis. Do you feel that fibrosis reduction of one stage would be of value?
Yes
No
4.
If all a drug therapy did was to stop the progression of fibrosis would that be of value?
Yes
No
5.
Suppose a drug treatment only worked for less than half of the patients, would it still be useful to have it available?
Yes
No
6.
Would you support asking the FDA to reconsider?
Yes
No
7.
If you would like to make a personal comment please tell us what you think.