obscure request. hopefully this data is easy to come by !!
I would say this should be easy to work around.. though I am puzzled by the wording...
is it that they need more information - to adequately assess, the systemic exposure to NUZ?
to me it seems like they tried really hard to pick something? maybe 'somebody' just wanted in at a discount.
keen for the webinar where hopefully they can express this better than my current interpretation.
great news 'NO safety concerns' in the advice..
GLTAH
Ann: FDA Guidance on NUZ-001 IND Application, page-9
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