$heff's $tation of $tocks & $olid DD

[rocketeer357]

FCSC .67 http://www.fibrocellscience.com/

CRL response accepted by FDA today. PDUFA for laViv®, for the treatment of moderate to severe nasolabial folds and wrinkles is June 22, 2011.

Shares traded as high as .79 before falling back to .60 midday.

In the initial submission, FDA panel voted 11-3 on efficacy but 6-8 on safety. FCSC did a follow-up clinical trial (FDA helped in the design) to address safety issues:

“Azficel-T was directly compared to a placebo injection as well as untreated skin in each subject. The study results were consistent with previous clinical studies, while providing a detailed examination of azficel-T activity at the microscopic level after repeated injections,” 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 study met all expectations, and importantly raised no safety concerns."

13.65 million dollar market cap.


Bad time to be relying on social security benefits in the US of A. Great time to be in the wrinkle-correction biz!