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