Item 8.01. Other Events

BioMimetic Therapeutics, Inc. has received an informal request for clarification from the U.S. Food and Drug Administration (FDA) consisting of six questions, some with multiple subparts, related to the AugmentŪ Bone Graft Pre-Market Approval (PMA) review. These questions focused on the specific characteristics and etiology of the bone defects treated in the pivotal trial, an assessment of the medical relevance, or lack thereof, of certain protocol deviations, further information relating to the recently supplied operative notes and specific statistical clarifications.

Per the FDA's request, the Company is providing a response to individual questions as each response is completed. The Company has already supplied responses to certain of the FDA's requests and expects to finalize its additional responses within the next two to three weeks. The Company believes these responses will further support the safety and efficacy of Augment, but there is no guarantee that the FDA will agree with this assessment.

In addition, in the fourth quarter of 2012, all of the Company's key suppliers successfully completed FDA manufacturing inspections. Though there is no assurance these inspections fulfill FDA requirements relating to the approval of Augment Bone Graft, the Company believes their successful completion suggests that these suppliers are well prepared for future Augment Bone Graft inspections, if any additional inspections are deemed necessary by the FDA. However, there is no guarantee that this assessment will ultimately prove accurate.

The Company reiterates its previous guidance of a final approvability decision by the FDA between April 2013 and January 2014.