Sounds to me like we will be able to justify a large ph 3 trial in 350mg based on current data.
In my heart of hearts, we can do a large ph 3 in 700mg as well, with a great design, and an appropriate patient pop. But idk. A years long process, considering the biopsy requirements. But with a solid partner or world-renowned university helping fund it, we should see a solid SP while we wait, imho. Remember in the N-22 data we have for 700mg, we have a p-value of .059. Today! Right now!
In my heart of hearts, we can do a large ph 3 in 700mg as well, with a great design, and an appropriate patient pop. But idk. A years long process, considering the biopsy requirements. But with a solid partner or world-renowned university helping fund it, we should see a solid SP while we wait, imho. Remember in the N-22 data we have for 700mg, we have a p-value of .059. Today! Right now!
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