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size, and this, with the same consumer protection, but this is then the mechanism to mitigate producer risk while maintaining consumer protection at a constant level.  And this consumer protection then is that implied by the FDA guidance test.

Thank you for your patience.

DR. KIBBE:  Is there anybody who would like to ask a few questions?  Efraim?

DR. SHEK:  Just a clarity.  We were talking about that this product is a combination of the formulation and a device.  Those proposed tests, do they de-couple both of them?  Because you have an actuator, you have a pump and other devices, and that might be the same for all the rest, whether it's the guidance or what you're proposing.

DR. OLSSON:  No, they do not de-couple the performance of the device and the formulation.  These are tested as a unit, as is appropriate, because that is what the patient experiences.

DR. SHEK:  But we might have different batches.  Let's say the actuator is being made and you are using it for various batches of the canister.  So we'll

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