Great insight.
Thanks awildana.
I have put together the main points that I can see from Dan Peres.
- The upcoming Phase 3 study will likely involve more than 200 sites and also expand into South America and Western Europe.
- We will attempt to tackle that challenge with partners.
- We know who the players are, but we will still have to decide whether to go with one or mix a few together.
- We plan to study NASH for at least the next 5 years in large-scale studies.
- Data will be a big concern for us as well. You also can’t forget that site personnel will be collecting the data you submit to regulators. Therefore, we are focused on what we can do to get the highest quality data from those sites.
- If you get good data you can shorten the study, which will save us money and also allow us to get the treatment to patients faster.
- We currently have a marketed compound based on the same technology. The product is called Travelan and is marketed as a dietary supplement.
- We have already scaled up and there will not be an issue with scaling production. The question is more around what we will need for this specific study.
That has yet to be determined.
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