Biotech Values

[DewDiligence]

Re: ICPT CC on REGENERATE trial

Purportedly due to slow enrollment, the trial protocol has been radically changed. This is the updated trial listing that ICPT says has the FDA's backing: https://clinicaltrials.gov/ct2/show/NCT02548351 .

The old trial design is described in #msg-113816778. The main change is that only one of the two primary-endpoint metrics—reduction in fibrosis and resolution of NASH—needs to be statsig relative to placebo in order for the trial to be deemed a success. I.e., with respect to the two metrics described above, the "and" requirement has been changed to an "or", which is a very big change indeed.

'jq1234' and I previously commented on the unwieldy design of the original REGENERATE trial (#msg-113834542, #msg-113923601, #msg-113834368, #msg-113826609).

p.s. Curious that ICPT did not provide the information from today's CC in today's PR.