Was it last year or the year before that I said it wont be approved until 2023/24. With Covid all over the US currently, recruitment will be delayed, generally (before covid), it would take 100 patients 12 months to recruit for burn related trials, in the current situation, expect much longer, 2025?
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- Ann: USA FDA approves Pivotal Trial IDE
Ann: USA FDA approves Pivotal Trial IDE, page-28
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