Fibrocell Science Inc (FCSC)

[Ned Serious]

http://www.hotstocked.com/8-k/fibrocell-science-inc-FCSC-1166951.html

December 13, 2011

Fibrocell Science, Inc. (“Company”) was advised by the FDA that it was unable to grant the Company’s request for orphan-drug designation for azficel-T for the repair of post burn contracture scars where surgery has failed, is contraindicated, or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient, based on the Company’s application dated August 30, 2011.

The ability to receive orphan-drug designation requires that population estimate for the designation is less than 200,000 in the U.S. Since the data presented to the FDA indicated that azficel-T can repair many kinds of dermal and subcutaneous defects, the FDA stated that the target population of azficel-T includes patients with wounds, scars and contractures induced by many sources.

As such, the Company was unable to provide an accurate population estimate, was unable to provide evidence that the prevalence is less than 200,000, and did not provide a plausible rationale for limiting the use of azficel-T to those patients in the proposed indication.