I don't believe the BLA has been refiled just yet. Expect there will be a formal ASX announcement for it but Silviu referring to state that FDA has looked and actively looking at it in the context what has occurred and coming next before approval.
At least, that's how I'd interpret for now.
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- Presentation on ASX Gems Conference on 21st June
Presentation on ASX Gems Conference on 21st June, page-14
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