The news from Tuesday night that the FDA had rejected BioMimetic Therapeutics' (BMTI) application to market its Augment product for bone healing was not really news in and of itself. During the panel meeting, the FDA representative basically said “over my dead body,” the panel members' votes were not uniformly supportive, and the general risk-averse nature of the FDA today meant rejection was almost certain.
What was less certain, though, was the tenor and details of that rejection. Would the FDA demand a brand new pivotal trial? Would the agency be content with just new analyses or a supplemental PK study? As it turns out, the FDA pursued a middle path, but one that leaves massive uncertainties for the company and its investors.
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BioMimetic Therapeutics: The FDA Gives A Smudged Map For The Minefields
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