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noticed going by there, the sample sizes in the IPAC-RS proposal are largely larger than were in the FDA proposal, and there's no question that that's going to be part of the package in terms of making it possible to do what they're planning.

I also should mention that the FDA's draft proposal is more liberal than it appears.  Remember, in Dr. Olsson's presentation, it came up that the implicit limiting quality standard in the FDA proposal is either 75 percent or 85 percent coverage within the 75-125.  That wasn't in the FDA proposal and this is sort of a reverse engineering issue because, remember, there was no proposal on that.  So I think that was more liberal than it was expected.

So I think I'd summarize this part of it by saying that yes, the IPAC-RS report does deliver as claimed on this, that this is an improvement in statistical methodology.  The only thing added here is you need to be careful in the choice of the constants.  I think you've heard some of that already from both Dr. Adams and Dr. Olsson.

This sort of weird picture is to give you an

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