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fewer acceptable batches are rejected by the PTI test.  This means that the producer risk is lower.  The gap is due to this more efficient discriminatory power of the PTI test and it's there by design.  This is what we want.  The gap is not an incidental feature of the test.  Industry needs to be able to approve products, if that product is of acceptable quality.

Another important point is that this curve here represents the draft guidance test curve exactly as written in the guidances.  That is not to say that it necessarily reflects the OC curves of the specifications for approved products on the market.

Now, this plot here shows three theoretical examples of the effects of the types of deviations that have been approved by the agency in the last decade.  We can see that the gap between the FDA curve with deviations and the PTI OC curve decreases with such deviations, and also importantly, this is achieved at the expense of eroding consumer protection as can be seen by these curves having a pretty high probability to accept pretty bad batches.

Now, we are not complaining that these

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