RE:RE:RE:RE:RE:Did Paul confirmed Phase 3 trial in NASH for HIV ?
In the guideline, the FDA indicates the criteria for general NASH "Identifying therapies that will slow the progress of, halt, or reverse NASH and NAFLD"
At the very least, Thera current proposed endpoint "Delayed progression in NASH with no negative impact on fibrosis" would satisfy one of these criteria. Given NASH-HIV patients conditions are generally worse off than general NASH patients, the benefits provided by Egrifta would likely outweight the risks. This is one of the acceptance criteria for EMA.
Still, both EMA and FDA probably are arguing for a better endpoint during this Phase 3 design as per common sense. One of the solution is to add it as AN ADDITIONAL ENDPOINT on top of all primary endpoints proposed by Thera. If the trial meets ALL of them, then great. If the trial meets most of them, then both the FDA and EMA would then use benefits/risks analysis for acceptance.