This phrase by dr Vic came before the recent guidance:
"We believe that our cell therapy processes and procedures are exempt under PHS Section 361, CFR 1271.10 or CFR 1271.15(b) same day surgical procedure. Therefore, we do not believe that we will be required to obtain Food and Drug Administration (“FDA”) drug or biologic like approvals, although there can be no assurance that the FDA will require our products to obtain approval in the future. "
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