I can kind of agree with that. the only reason why is because this is the only study that was open label. Meaning that an interim analysis could be done by an IDMC. However, I don't believe that management was privy to results. But at the same time investigators do probably get feedback from patients on whether a treatment is working or not. In that sense, you can't assume that the placebo is the drug that is working well.
Having said that what I think will happen is that the primary endpoint will be met. However, worst case scenario is that the primary endpoint will be close. Comapny has stated that anything above 5% improvement compared to placebo will warrant further investigation. However anything below 5% will be bad.
From what I have seen with the ad hoc data after only 3 months of treatment of emricasan and being able to improve compared to placebo with stat sig, means that the results for the POLT trial should be good. Good luck to us all who are holding.
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