and the protocol will soon be submitted to both th

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and the protocol will soon be submitted to both the FDA and the Cornell IRB.

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Protocols generally go to the IRB first so they can approve before going to the FDA. It saves time in the process. Finalized in December sent off to the FDA . The FDA didn't review until when? Timeline is supposed to be 30 days. After the review FDA suggests changes so changes are implemented and sent back to the IRB and FDA.