GREY:ATBPF - Post by User
Comment by
drippingsnoton Sep 09, 2020 6:07pm
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RE:RE:RE:RE:RE:Dr. John Wallace
RE:RE:RE:RE:RE:Dr. John WallaceThat's a good point Marky but I don't think it would have solved anything.
If you left out 150 mg, FDA would likely ask ... How low can you go before it fails?
We would probably be in the same position, doing a Phase2/3.
Back to my original question from a few weeks ago ...
In Phase 2/3, we obviously get to look at the PART 1 data to determine the dose.
It's like a window into our Phase 3 trial.
Who wouldn't want to design a trial in a two-step fashion so you can have an early peak to see how things are going? I think Stauffer said (at BioPUB) he would always design it this way going forward. I can see why.
That's just how I'm seeing this design as a small PART 1 (Dose Determination and an unsuspecting window into the continuation) and then a large PART 2 (Continuation).
Can anyone clarify if I've got it right or wrong?