right !! super left field query. seems like they very much stretched for this puzzle piece. I think Ice' or someone else? made a comment alluding to that it might be someone new in the FDA trying to validate their job ha..
could be bang on.
I like the language 'straightforward'. Seems MT and team have already well and truly mulled on it.
Ann: FDA Guidance on NUZ-001 IND Application, page-11
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