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p3analyze

03/06/12 1:25 PM

#138276 RE: pcrutch #138274

Just dug that up - the key phrase paraphrased is "if a conventional approach is taken then a plausible boundary would be so and so".
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exwannabe

03/06/12 2:28 PM

#138282 RE: pcrutch #138274

According to Bernstein's report based on their conversations with Merck kgaa and their experts. I can email it to you if you like, but I wont post it.



I assume that this is .025 total alpha, knocked down to .024 for the IAs?

Presumably the FDA insisted on that for purposes of the SPA. Any clue why?