BioMimetic Therapeutics, Inc. announced it has submitted both the pre-clinical pharmacology/toxicology and quality/manufacturing modules of its Premarket Approval (PMA) application for marketing of Augment Bone Graft in the US. These are two of the three parts, or modules, required for a complete PMA application to the FDA. The company intends to file the third and final module, containing the clinical data, in the fourth quarter of 2009.
A modular submission breaks the PMA document into three sections or modules filed at different times that together become a complete application. The modular approach allows the applicant to potentially resolve any concerns noted by FDA earlier than would occur with a traditional PMA application, and may ultimately shorten the review and approval timeline.
The submission of the first two PMA modules is a significant accomplishment for BioMimetic, commented Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics. These submissions allow FDA to begin their review of these modules well in advance of receiving the final clinical data later this year. We believe this modular strategy will facilitate the most efficient and timely review and ultimate FDA approval of Augment Bone Graft for orthopedic applications.