If memory serves wasn't this the 2nd trial and the first one failed to reach significance?
It just barely missed on the pain endpoint. 0.06 or thereabouts.
I wonder if this is enough for approval?
For the Fibro pain label - almost certainly (barring some unrevealled negative). One stat sig ph iii, one almost stat sig ph iii, and one randomized ph ii.
For the Fibro syndrome label - it will depend on the first ph iii. If the first ph iii was p<0.15 in both treatment arms then that plus the fairly strong results in this ph iii would seem a reasonable basis to grant the label.
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