BioMimetic Therapeutics, Inc. BMTI announced today that it received
a comprehensive post-panel response letter from the FDA related to the
Company's Pre-Market Approval 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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