Clinical trials are very expensive to do, you'd want to make sure that the FDA is happy with the documentation you provide about your molecule, the manufacturing, test done so far etc. and giving the FDA the opportunity to have input on your trial design etc is also useful. You shouldn't compare the FDA with policemen but rather view it as critical partners in the development of your drug (but they do police of course). Early involvement of the FDA is a good thing
Ann: Update on meeting with US FDA, page-4
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