Biotech Values

[DewDiligence]

I'm a bit skeptical that someone with gallstones developed high liver tox during the treatment period from gallstones alone.

You’re wise to be skeptical until there are more data to support this claim.

Would someone with gallstones actually have been able to enroll in the study?

Well, we know it happened. Whether this constituted a protocol violation is unclear (and probably irrelevant); the exclusion criteria for the study were as follows:

Subjects are not eligible if they meet any of the following:

1. Pregnant or breastfeeding.

2. History of clinically significant diseases, as determined by the investigator.

3. Safety laboratory abnormalities at screening which are clinically significant.

4. Positive screening test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV).

5. Use of chronic prescription medications within 3 months, acute prescription medications within 14 days, or systemic over-the-counter (OTC) medications within 7 days of the starting the study.

6. Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.