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DewDiligence

12/16/19 2:45 PM

#227733 RE: miljenko #227732

ICPT—From a strictly medical standpoint, I actually think the non-invasive tests available today are sufficient for treating NASH patients, unless the doctor suspects that a patient has a different liver disease—or two liver diseases (NASH + something else) simultaneously.

However, for third-party payers, insisting on a biopsy seems like a no-brainer given the large patient population, the estimated yearly Ocaliva price,* and the probable need for rest-of-life treatment.

*The NASH price at 25mg/day will presumably be priced differently on a per-milligram basis than the PBC price at 5-10mg/day.

DewDiligence

12/16/19 8:23 PM

#227756 RE: miljenko #227732

Pumpers are promoting ICPT as GILD acquisition target...

I'm on record that nobody will want to acquire ICPT (at a premium to the market) because Ocaliva is simply a bad drug.

p.s. I am not short the stock, although I probably should be based on fundamentals.

DewDiligence

12/16/19 8:45 PM

#227758 RE: miljenko #227732

ICPT—The intense focus of today’s webcast’s on discrediting liver biopsy as a NASH diagnostic was a form of lobbying directed at members of the upcoming FDA advisory panel, IMO.

Ocaliva’s sales prospects in NASH will be substantially diminished if the FDA label mandates a pre-treatment biopsy to establish a threshold fibrosis level, and this is the kind of issue where the FDA will likely seek guidance from the advisory panel.

ICPT is well capitalized and doesn’t stand to gain anything from pumping the share price. The real target audience for today’s 3.5-hour “investor” webcast was not investors!