Being cautious within timeline ... up to 90 days.
" The timeline for granting the ODD is up to 90 days."
TBH, glad to see some restraint from MT when required, as indications from FDA were we would continue from "hold" stage of ODD application when data requested, so about 45 days to go ... but no guarantee on timing, other than 90 days or less.
Ann: Positive clinical data filed with FDA to support ODD request, page-6
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