Friday, May 07, 2021 9:54:51 PM
Typically, a pre-INd meeting with the FDA is where both parties get together and come up with a plan to develop the IND. FDA can help and provide guidance into what should be included and how the IND should be structures, endpoints, etc., but the actual IND has not yet been developed at this point. All the input provided by the FDA and the outcomes/agreement coming out of the pre-IND meeting goes into developing the IND.
Hope this helps
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