RE:RE:Did Paul confirmed Phase 3 trial in NASH for HIV ?
1/ Pauls has been around this field for 35 years, so it tells me he meant Phase 3.
2/ He also said:"we need to agree to endpoints, we need to agree to sample size or cohort size, and that's what we're trying to do at the moment".
2.a "we need to agree to sample size or cohort size" : There is a different in requirement of number of patients in the trial. In my opinion, this is not a big deal.
2.b "we need to agree to endpoints":
These are Thera proposed endpoints for Phase 3:
+ Normalization of liver fat (5%) with
+ Delayed progression in fibrosis with no negative impact on NASH, or
+ Delayed progression in NASH with no negative impact on fibrosis
+ In Silico mathematical modeling of long term reduction of clinical events
These are FDA guilines:
+ Identifying therapies that will slow the progress of, halt, or reverse NASH and NAFLD
Guideline Endpoints:;
Decrease in fibrosis of at least 1 with no negative impact on NASH
Normalization of NASH score with no negative impact on fibrosis
The highlighted endpoints seem to be the sticking point. The other FDA guideline endpoint should be a non-issue for Egrifta.