I think a key factor is what kinds of injuries and medical conditions are included or excluded from the protocol. If the parameters aren’t exceedingly tight, 100 could take MUCH less than a year to enroll. But they do need to get through IRBs before enrollment can begin, but a hospital IRB that already worked with ReCell wouldn’t give it the same kind of thorough review as one that didn’t.
Ann: Pivotal Soft Tissue Trial Receives US FDA IDE Approval, page-7
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