I disagree that it’s two years from approval. The safety/risk data for the most part are already in place, and the kind of healing timelines are maybe 6m max, so it all depends on the speed on enrollment, and I had a gruesome injury and they offered me a trial that COULD grow my skin back in its natural color with minimal scarring and so on over the usual treatments, you bet id be signing up.
Ann: Pivotal Soft Tissue Trial Receives US FDA IDE Approval, page-5
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