1/4/2012 5:56:07 AM
FRANKLIN, Tenn.--(BUSINESS WIRE)--BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) announced today that it received a comprehensive post-panel response letter from the FDA related to the Company's Pre-Market Approval (PMA) application for Augment® Bone Graft for use as an alternative to autograft in hindfoot and ankle fusion procedures. The FDA acknowledged that the independent Advisory Panel voted in favor of a reasonable assurance of safety, effectiveness and a positive benefit:risk ratio; however the FDA went on to state that “[n]otwithstanding [the Advisory Panel’s] recommendation, the PMA, without additional information, must be considered not approvable [and that]. . . to place [the Company’s] PMA in approvable form, [the Company] must amend it to include the following . . .” The FDA then listed the information that BioMimetic would need to submit for the application to be approvable, and outlined a pathway that could potentially lead to approval without additional clinical trials to support the safety and effectiveness of Augment.
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