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PolyNovo Finalises US Trial Report and Updates PMA Submission Plan
12:09pm on Friday 29th of May, 2026 AEST
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Healthcare
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PolyNovo Finalises US Trial Report and Updates PMA Submission Plan
12:09pm on Friday 29th of May, 2026 AEST
Key Points
Clinical Study Report finalised with 12-month data
PMA submission timeline extended to end of 2026
Updated FDA guidance prompts inclusion of extra manufacturing validation
18-month follow-up data to strengthen submission
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