I believe you need time to incorporate the observation and measurement 30 days after experimentation, ala week 1 after procedure, week 2 after procedure, etc.... If it completes on 10/7, I would expect 11/6 for measurements to completed. Submission shortly there after. Taking into account holidays, we maybe looking at mid December or early January before a response from the FDA (maybe another pump before Xmas so people have holiday money).