I agree with aij5. The novel portion of this particular product is the sensor and reporting aspect, the drug is already an approved product. If the device portion is approved it has the potential to be used with other drugs. However, if the device somehow controlled the dosage administered to the patient then there would be more hurdles to cross from a review standpoint. As it stands now the main purpose of the device is to communicate that a patient has taken their medication and it supposedly does not significantly alter the metabolism of the drug in any way.