“To determine whether the improvement over available therapy is substantial is a matter of judgment and depends on both the magnitude of the treatment effect, which could include duration of the effect, and the importance of the observed clinical outcome. In general, the preliminary clinical evidence should show a clear advantage over available therapy.......”
Muzza , “the magnitude of the treatment effect “. NEU has ticked this off.
And the” duration of the effect “ is also ticked off by virtue of the ongoing nature of the drug. It’s not a cure. As in a cancer type cure. It’s disease modification which requires daily dosing for life.
We won’t have long to wait to find out about this. I’m quietly confident. And this may be why Jon was confident in suggesting RAETA was a good comparison.
He would never come out and say he was expecting or hoping for Breakthrough Designation!
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