Replies to post #191487 on Biotech Values

[ghmm]

ICPT:

I don't follow ICPT as closely as others here. In general I don't like co-primary endpoints in reading Adam's writeup it seems they missed on NASH resolution in Phase 2 granted the larger trial size should help here. That being said and not being knowledgeable here it would be a guess but I would guess higher than 20% odds of success :-)

[DewDiligence]

FLINT was not statsig on resolution of NASH in the ITT analysis. See jq’s link in #msg-113831454 for more details.

[jq1234]

ICPT OCA NASH ph3 trial design with co-primary endpoints is tough, maybe just better than an outcome trial, that's all I can think of. Although 1400/2500 patients sound a lot, excluding stage 1 patients, consider it is 3-arm trial, interim vs final, co-primary endpoints, alpha splitting, not as large as the numbers suggest.

Leerink's note is quite accurate compared to others. I saw some analysts' notes about setting high bar to deter competition, that's bull. What's so great about setting the bar so high it increases risk one will have difficulty meeting this bar?

I wonder which part of trial requirements came from FDA, which part came from EMA? Maybe ICPT wanted to jam requirements from both agencies into one trial. Maybe they'd be better off by conducting two separate trials to satisfy each agency rather than jam two into one tough single trial. I don't have any evidence this is the case, just speculate as ICPT disclosed little else in cc than PR.