Replies to post #175517 on Biotech Values

[zipjet]

ICPT

Knock it down to 300 and I will be back in.

To have SAE's related to CHD in a population old enough to have NASH with comorbidities of diabetes and high blood pressure should be no surprise.

Frankly, I would be surprised in the absence of those.

Of course, the absence of stat sig tells us nothing.

In the case of the rats liver slide, a picture is worth more than 1000 words.

[biomaven0]

>>so leaning on that as an excuse/mitigation doesn't fly

I'm unclear what it is you want them to say here. They reported that the DSMB said there was a non statistically significant imbalance, and I'm not sure what else there is for them to say. Do you really expect the company to explain that non-significance isn't that meaningful here given the sample size?

Peter

[DewDiligence]

ICPT—I believe them that they don't have the actual unblinded numbers. But they surely know how difficult it is for an AE to be stat-sig in a trial that size...so leaning on that as an excuse/mitigation doesn't fly…

I agree with the second part of your sentence but not the first part. I rather doubt that ICPT was told there was a non-statsig safety imbalance without also being told the degree of the imbalance.