BMTI - BioMimetic Therapeutics, Inc. (the “Company”) previously announced that it would be meeting with the U.S. Food and Drug Administration (“FDA”) in July 2011 to discuss the next steps with respect to the Company’s Pre-Marketing Approval (“PMA”) application for AugmentTM Bone Graft. That meeting has been scheduled to occur on or about July 11, 2011. As previously announced, subsequent to the meeting, the Company expects to receive a letter from the FDA in September 2011 containing follow-up information from the July meeting. The Company expects to make a public announcement regarding any requirement or request made by the FDA in that letter. The Company continues to anticipate approval of Augment in early 2012 depending on the FDA’s requests or requirements, if any.
The information presented in Item 7.01 of this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, unless the Company specifically states that the information is to be considered “filed” under the Exchange Act or specifically incorporates it by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act. "
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