I assume Avita one is class II resubmission with minimal effort fix it and it will get the approval in anytime from now, if shorts playing, that’s going to be a loose for them…
- Class I resubmissions: If the FDA determines that additional information or data from the sponsor can easily address minor deficiencies in their application, it is classified as a class 1 resubmission. Upon resubmission, the FDA has two to three months to review these applications.
- Class II resubmissions: If the FDA determines that significant changes or new data are needed to address sponsor deficiencies in their application, it is classified as a class 2 resubmission. Upon resubmission, the FDA has six months to review these applications.
Ann: AVITA Medical to Announce First Quarter 2024 Results, page-6
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