FCSC closed the session at $0.619, or 7.57% down from the previous close on a trading volume of almost four times the average. On Wednesday this week the company announced that the FDA has accepted for review its complete response letter for azficel-T, FCSC most advanced product candidate that is in Phase III of its testing and is being developed by the company in the past several years. It is aimed for the treatment of moderate to severe nasolabial folds and wrinkles, and although it sounds like a promising product that could increase FCSC sales it is yet not certain if or when that could happen.
The acceptance of the response letter still does not guarantee the approval, and the final decision is to be expected later this year as the FDA will have a six-moth period of time to review the submitted results from the final clinical studies. Though the positive projections, even if the products gets the approval Fibrocell’s ability to start commercial production immediately does not seem secured. The company emerged from its bankruptcy proceeding in September 2009, though with its former lenders taking a large part of the ownership.
FCSC latest 10-Q for the periods ended September 2010 also reveal that the company is again in a very unenviable financial state. At the end of last September Fibrocell had cash of about $200,000 and a working capital deficit of over $1 million. Some cash for working capital needs has been raised through the issuance of preferred stock and warrants since then, but as stated in the report it if no additional funding is found the company is likely to cease operations.
