My estimate would be enrolment concluded by the end of calendar year 2025. Another 1 year to get to 404 day data point. 6 months to collate data. 1 further year to get FDA approval. So I'm expecting 1st iPPS sales in USA in around mid-2028, everything goes relatively smoothly.
It'll be interesting what TGA does, with some FDA guidance appearing to already have been received by PR and co.
research reports and media, page-4231
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