Alert..bought shares of FCSC.OB at .76 & .77 in my portfolio as they have a forward-looking catalyst w/ an FDA approval date. The company is awaiting FDA approval of an autologous therapy called LaViv for the treatment of moderate to severe nasolabial folds & wrinkles. They have a PDUFA date of June 22nd. The story is intriguing and the company is in a unique position to be the first autologous therapy approved in the aesthetic field and only the third on the market (Provenge-DNDN & Synvisc-GENZ & Carticel) are the others.
The company conducted their Phase III trial with a Special Protocol Assessment where they showed statistical significance in their clinical endpoints. The company has also already gone through an Advisory Panel Meeting and received a CRL from the FDA. They submitted their response in December & it was accepted in January. Company has an excellent chance for approval in June.
Yesterday Fibrocell presented at the Wall Street Forum and it was a solid presentation. I encourage everyone interested to listen to it. http://www.wsw.com/webcast/wsaf18/fcsc/
I had an opportunity to speak with the CEO & CFO after the meeting yesterday. I will be posting more on them later tonight. Volume is 101,000 with 40 minutes left in the trading day. 10-day volume is 125,000. Ameritrade requires a call in on this stock so be aware of that.
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