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donotknowityet

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donotknowityet

Re: iwfal post# 41443

Thursday, 02/01/2007 12:47:05 PM

Thursday, February 01, 2007 12:47:05 PM

Post# of 253121
MC-1, stroke, Iwfal:

The company specifically stated that stroke was not part of the SPA. You are right that the data are not convincing. I would think it raises a red flag, and the FDA would have wanted some non inferiority in the result at least.

Do you have any explanation why stroke is not part of the SPA at all? The sample size in all arms will be 5 times bigger, so a somewhat more meaningful data should result.
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