Список проголосовавших за комментарий " <table class="BriefingDataTable" border="0" cellspacing="0" cellpadding="0"><tr> <td class="tickerColumn"> </td> <td class="articleColumn">Intercept Pharma: Changes to REGENERATE lower the hurdle for success — FBR & Co. (117.77 +5.08)FBR notes on February 10, ICPT provided an update on its REGENERATE Phase III trial with obeticholic acid (OCA) in NASH patients with liver fibrosis. As a reminder, the 2,000-patient international study was initiated in September 2015 with the co-primary endpoints (1EPs): 1) fibrosis improvement w/no worsening of NASH; and (2) NASH resolution w/no worsening of fibrosis. The study includes an interim analysis after 72 weeks of treatment in 1,400 patients, which is intended to serve as the basis for seeking initial regulatory approval. <strong>They consider ICPT as trailblazing NASH drug development but in an environment where regulatory requirements for approval are unclear. They think the study's changes reflect this view as significant evolution has occurred as to what LT clinically meaningful outcome would be acceptable in NASH.</strong> They also think two noteworthy changes, demonstration of one of the 1EPs and not both, and an interim analysis conducted after enrollment of 750 patients, lower the hurdle for success, which are positive developments. However, although the OCA FLINT Phase II results were strong, firm remains uncertain whether the level of improvement seen with OCA will be adequate to demonstrate clinical benefit outweighs OCA's known negative safety signals; Market Perform.</td> </tr></table>"