Highlights

• Probably most F3s from the get-go [would be treated with a NASH therapy], and then for F2s probably half of them will be treated from the beginning, and the other half will be treated in a more delayed fashion. Now, of course there will probably be 20% or so of patients that might be too sick, too old, with too many co-morbid conditions, with too many other drugs that will be treated, so at a maximum that would apply probably to 80% of F3 patients.
• [Results from Ocaliva’s Phase III REGENERATE trial] is a good first step, again it is the only drug that has shown this level of efficacy in a large Phase III trial, because it is much easier to succeed in a Phase II trial, especially if they are small, than in a Phase III trial. So, no, I am rather optimistic about the data, in terms of fibrosis, it is also something that confirms earlier data, so there are two independent studies that have shown an effect on fibrosis, so that is good, therefore I am not disappointed by this as far as the fibrosis results.
• Of course, it [the elevated LDL cholesterol level associated with Ocaliva] makes managing therapy a bit more complicated because you have to look for that, you have to decide whether to use the statins, and then if you do, you have to monitor them in a certain way, and try to navigate through the potential side effects. I am not saying it would be very easy, it will take a bit of dedication to manage these patients optimally. However though, that is nothing really compared to what we have done in viral hepatitis 10 years ago with interferon. I would say