@Mozzarc
thanks for your explanation. I understand the stats. I am not so sure that they cover all areas on which FDA might challenge us for more information.Yes, i think the stats prove some particular things very well, as you have made clear.
In one set of results some patients recorded less improvement at the end rather than half way through. My guess at the time was they were feeling so good that they overdid what they were capable of. Maybe the FDA will want to know more about that over a longer period
I think we have only nailed that the 2mg dose is the right dose if DMOAD and safety are analyzed separately for dosage. If they want a scatter plot we may have more work to do.
Let's hope there are few and simple questions that can be handled in what has been proposed.
I am hoping for a response soon!
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