(1) PRIORITY REVIEW.—The term ‘priority review’, with respect to a human drug application as defined in section 735(1), means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application...
Given we are 'in the process of preparing submissions..' I wonder if this application will be before or after our EU PIP application in Q4 20..
Perhaps after (or at the same time) when we can use the EU 2b approved trial to then apply for Orphan status in the US. So maybe start EU and US H1 21.
An FDA Act that may be relvant to ATL-1102 FDA, page-3
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