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hankjoejr

05/07/21 9:50 PM

#34757 RE: jeremyblack #34756

A MM screw job?

rrao11

05/07/21 9:54 PM

#34758 RE: jeremyblack #34756

Because the IND was already prepared and submitted for review and approval, and the FDA was asking questions or clarifications on the submitted IND. Hence, IND meeting.

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