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Wednesday, January 13, 2021 1:40:56 PM
In USRM's case, I didn't think the woman was all that clear or compelling in her presentation while the FDA lawyer seemed, unfortunately, very competent and knowledgeable. True, the judges asked questions and I guess the most hope was in the judge kind of cross-examining the FDA lawyer about his objections based on the claim that USRM didn't provide arguments for the active healing attributes of the cells which the judge pointed out was there.
Toss up in my opinion based on today's hearing. No clear indicator.
What I took was that FDA argues that SVP is a derivative of the fat cells and what it being put back into the person is significantly different than what is being extracted and therefore it is not excluded from FDA regulation since it doesn't come under the exemption section.
FDA example was related to skin grafts where skin is removed, cleaned, trimmed and then put back as skin whereas, in his argument, fat is removed and a cocktail of cells (not fat) is returned to the patient, thereby being a substantially "different" substance.
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