As I suggested a couple of days ago, BioMimetic Therapeutics (Nasdaq: BMTI) did indeed get a thorough grilling from the FDA's advisory panel.
The good news? The panel ultimately voted in BioMimetic's favor on the three key summary questions of safety, efficacy and benefit/risk. What's more, the foot-and-ankle specialists (the key intended application for BMTI's Augment product) were supportive.
The bad news? The FDA (and the panel, to some extent) clearly has concerns about the product, and it is far from certain that the agency is going to grant approval to BMTI to market the product.
A Meeting With A Challenging Tone
While some observers of the meeting (or those who followed the tweets of those following the meeting live) may have felt the panel was contentious and negative, it didn't strike me as all that unusual relative to recent meetings. Certainly there were some pointed questions, and the panelists took the company to task more than once for deficiencies in the study and/or its results, but it is frankly rare to see these meetings conducted as love-fests for the applicant.
To read the full piece, please go here:
BioMimetic Clears One More Hurdle
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