Untitled Letter could leave Mimedx in a position of strength
FDA is concerned about Safety and Efficacy. The fact that Mimedx has sold close to 180,000 units without one "ADVERSE EFFECT" clearly makes them the leader in this category. The FDA has no desire to shut down a company who's product is so effective especially in the Veteran's Hospital. By choosing the market Leader and Pete has already said his goal is to get the FDA completely happy and comfortable with the Mimedx process. KEEPING IN MIND MIMEDX HAS HAD 2 INSPECTIONS AND PASSED WITH FLYING COLORS! They were both granted NAI's So when Mimedx makes the FDA happy this will put up another roadblock for the competition to try and stay in the race. In addition this CMS savings of 75 million is another roadblocks for the competition. It should be an interesting race!
I think most of us know this, or should know this already.
There are two questions that seem more important now. Has MiMedx done anything recently to alter the production process since the inspection in July 2012, and what exactly did the FDA find objectionable in their most recent visit at the end of July 2013?
Doctors can clamor for new drugs all day long, and we can agree they might be necessary, but that isn't likely to sway the opinion of the FDA.