With the standard pill, not containing the event marker, there were 6 clinical trials done to get the drug approved. With the addition of the marker the new combination product required new clinical trials using the prior 6 trial data sets in addition to one more trial that showed the ability of the patient to use the system successfully. If you read the limitations of usage section and the disclaimer you will see that there may be a delay or the pill may not even register at all, that the ability of the drug to improve patient compliance has not been established, and that it should not be used to monitor real time or in an emergency. From my understanding the only theoretical upside that this sensor embedded drug has is that it allows caretakers and patients to track IF they have taken the pill, to prevent a person from going off their meds or to prevent double dosages in patients who are forgetful. According to the disclaimer and the CDER clinical review this device does not reliably perform that task, what good is a sensor that doesn’t reliably sense? It’s really only effective as a drug, the device portion is just trivial. I understand that the company covered their behinds by adding the disclaimer so that they aren’t claiming something that they cant provide, but how can you put a product out that implies it can perform a certain task and then add a disclaimer that says it probably cant perform the task and you shouldn’t rely on this product performing the task successfully. How is this right?