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[–]FrenologistSaving the World 1 Cranial Exam at a Time 2 insightful - 1 fun2 insightful - 0 fun3 insightful - 1 fun -  (0 children)

Take a look at this FDA conference from earlier today. The link will start at about 4:20:11. You only need to watch for about 5 minutes.

https://www.youtube.com/watch?v=WFph7-6t34M&t=15611s

Does that answer your question?