Here is a timeline for you to consider;
Study to start within 6 months - Jan 2020
If there is to be about 100 patients to be enrolled then it usually takes about 12 months - Jan 2021
6 months of follow up of last patient - July 2021
Approval maybe Dec 2021
The best part of this announcement is that surgeons will be able to apply for an exemption to use it.
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- Ann: Pivotal Soft Tissue Trial Receives US FDA IDE Approval
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avita medical inc.
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Ann: Pivotal Soft Tissue Trial Receives US FDA IDE Approval, page-6
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