An iData’s report states that just the U.S. market alone for aesthetic facial injectable products is valued at almost $860 million in 2010. See the full article for more information.
Fibrocell Science Inc. stock symbol is (NASDAQ:FCSC) trading as of this blog $1.02/shr
4 weeks ago Fibrocell Science submitted the requested study that the FDA asked for in the previous Complete Response (NYSE:CR) letter issued by FDA regarding the Company’s Biologics License Application (BLA) for azficel-T, proposed brand name laViv®, for the treatment of moderate to severe nasolabial folds and wrinkles. In December of 2010, the Company submitted data from a three-month assessment for this study. The Company has a PDUFA action date of June 22, 2011 for this BLA.
“The submission of the final study report is a significant milestone for our lead cell therapy, azficel-T,” said David Pernock, Fibrocell Science Chairman and CEO.
“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.”