BioMimetic Therapeutics, Inc. (BMTI)

[fredman]

The Company previously announced that, based on discussions with the U.S. Food and Drug Administration (“FDA”), it expected to receive a follow-up letter from the FDA around September 2011 outlining post-panel requirements for approval of the Company’s Pre-Marketing Approval (“PMA”) application for Augment® Bone Graft (“Augment”). As part of the review process, the Company continues its discussions with the FDA, but has not yet received this letter. Since the FDA is not bound by a specific deadline for communicating the Company’s formal post-panel requirements, the Company believes that the absence of a letter at this time should not be construed as suggestive of the FDA’s position on the Augment PMA.

While the Company anticipates receiving the FDA’s formal letter in the near future, the Company is currently unable to provide more specific guidance regarding the timing. The Company plans to make a public announcement shortly following receipt of formal communication from the FDA, and expects to make no further public comments on the subject until such announcement.

Source: http://www.sec.gov/Archives/edgar/data/1138400/000114420411056401/v236549_8k.htm