Friday, March 14, 2014 10:58:37 PM
We now have all the MACs in place with Florida as the last addition for Epifix coverage. This is a big deal and Management will eventually increase revenue guidance.
We have management scheduled to meet with the FDA on Amniofix. At this point, I believe that no news is good news. There is no indication that the FDA has notified MDXG to pull Amniofix from the market while they seek a BLA. Adverse events with Amniofix are virtually nonexistent. Decent chance that MDXG will be allowed to continue to market Amniofix under specific labeling. Without widespread coverage (trials will solve that), Amniofix is in position to provide supplemental revenues behind Epifix.
But make no mistake, Amniofix is a potential BILLION plus dollar product. The applications for Amniofix are numerous and epitomizes what Regenerative Medicine is about. Amniofix certainly has much more revenue potential than Epifix. I don't think many investors know this yet...
Recent MDXG News
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