BioMimetic Therapeutics, Inc. (BMTI) Completes Submission of PMA Application for FDA Approval of Augment(TM) Bone Graft
2/18/2010 9:54:03 AM
FRANKLIN, Tenn.--(BUSINESS WIRE)--BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced it has submitted the third and final module of its Premarket Approval (PMA) application for marketing of Augment™ Bone Graft in the U.S. This final module, containing a comprehensive review of the clinical data related to Augment, completes the PMA application to the FDA. The Company previously announced the filing of both the pre-clinical pharmacology/toxicology and quality/manufacturing modules with the FDA in June of 2009. Upon receipt of the clinical module, the FDA begins its 45 day filing process as the first step in the formal review of the PMA. The Company expects the agency to schedule an advisory panel review sometime later in the year.