Biotech Values

[iwfal]

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.

Will post more thoughts as I dig around.

Clark