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Re: steveporsche post# 136914

Sunday, 02/12/2012 4:17:21 PM

Sunday, February 12, 2012 4:17:21 PM

Post# of 252255
CLDX, If I can but in ...

On the 011 P2B, I think everybody agrees that failure to be stat sig is not the end of the game.

I would say though that it needs to show more than "the same or better" as a point value. Something like 15% vs 5% would make me happy (and not be stat sig).

On India, the FDA will not balk just because of the India locations. They will keep a close watch on that though, so the danger is that the locations actually do have serious violations and anomalies.

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