Enrollment is slower than plan. Common. I'm hoping we're expanding enrollment along with site expansion, but the company has not indicated that, so likely not.
They have not given any detail on the component structure of the 2/3 in any presentation or forum, including clinicaltrials.gov. What they disclosed thus far looks like any well designed advanced phase 2 but heavy on direct clinical benefit endpoints like a phase 3. In other words, a small phase 3. No progression criteria or endpoint differentiation has been disclosed.
Complimentary with progression criteria, phase 2/3's also typically have an interim, for futility. But I suspect that is skewed by the fact that many phase 2/3's are for cancer trials where mortality and hardship loom larger. We do not need an interim, so Missling's hesitancy is justifiable, especially given the relatively small size of our n. He doesn't want to compromise statistical power and increase chance of type 2 errors, and that's understandable.
Would be nice to know more about the 2/3 structure, but we have probably gotten everything were going to get detail-wise.
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