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FOOD AND DRUG ADMINISTRATION - page 97 / 263

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First of all, it seems that the 5 percent alpha is a fixed given, and I didn't hear a lot of discussion about that.  How is that number arrived at?  What goes into the thinking that says that's an appropriate level for consumer protection?

MR. SCHUIRMANN:  Well, I think that it's mainly a matter of tradition.  There are a number of FDA testing procedures that have adopted 5 percent as what's called level of significance, maximum tolerable chance of approving something that shouldn't be approved.  There are some other situations in FDA regulations where the de facto level of consumer protection is 2.5 percent.  There certainly could be and probably have been arguments that that's what we should be using here.

Certainly if discussions led to the assertion that not 5 percent but 2.5 percent, or any other number you would care to specify, is the appropriate level of consumer protection, then IPAC-RS could have reverse engineered the FDA proposal, found out what level of quality has a 2.5 percent chance of being approved and called that the limiting quality and designed their test to assure that same limiting quality and all those things

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