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Judgment & ambiguity · Prioritizing without clear signal

A pre-IND meeting is six weeks out and three workstreams are behind: the tox package has a gap, the CMC section needs more batch data, and the clinical protocol is unreviewed. Nothing is clearly the long pole. How do you decide what to protect?

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I sequence by what the agency actually needs to hold a productive pre-IND versus what can come after, because these three don't carry equal weight to that meeting.…

The full answer: structure, worked example, likely follow-up.

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