Fibrocell Science, Inc. Submits Final Data from Histology Study to FDA
"The Company’s final study report contained data from the 29-patient blinded study (IT-H-001). FDA participated in the design of the protocol and data analysis plans. As was the case with the three-month report, there were no unexpected results in the six-month report, and the study provided additional data to support the azficel-T safety profile seen in the clinic."
“This study, which objectively evaluated the effect of repeated azficel-T injections at three months and six months, has met all expectations. As anticipated from the extensive prior clinical experience, no clinical concerns were identified by either direct or comparative observations of the cellular morphology and integrity of the dermis, subcutis, or epidermis when biopsies from tissue treated with azficel-T were compared with either placebo-treated or untreated tissue,” said James Merritt, M.D., Clinical Advisor to the study and Chief Medical Officer of CBR International Corp., a Colorado based research firm who provided medical advice to Fibrocell during the study. "The detailed microscopic analysis of tissue treated with azficel-T during this study support Fibrocell’s response to the CR letter, and we believe we have met FDA requirements.”
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They completed exactly what the FDA wanted and found zero issues. This will get the green light IMO. This first approval is just a gateway to many other approvals coming for many other uses, take a look at the investor presentation.
