9/8/2010 10:34:52 AM
FRANKLIN, Tenn.--(BUSINESS WIRE)--BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced it completed its 100 day Premarket Approval Application (PMA) meeting with the Food and Drug Administration (FDA) regarding the review of Augment™ Bone Graft for the treatment of foot and ankle fusions in the U.S. The FDA generally meets with the PMA sponsor approximately 100 days after the filing of the PMA with the purpose of discussing the status of the application. During its recent discussion with the Company, the FDA raised no unexpected issues that would impact the timing for an upcoming Orthopedic Advisory Panel Meeting or potential approval of Augment. The Company continues to anticipate that the panel meeting will be held by early 2011. If the panel determines the product to be safe and effective, the Company expects approval of Augment by the FDA in mid-2011.
comments powered by