Scenario #1 is Mimedx pleads their case of why the injectable has not been manipulated, FDA agrees and Mimedx has just tightened up the standards of the 361 process! This is key in my opinion because the FDA is all about Standards. They want to tighten the 361 process so down the road they do not have any back lash but a more specific process on conducting 361. It is no accident they want to talk to Mimedx for they are clearly way out in front as far as most units sold under 361. (180,000 units by the way) By getting more defined as to what manipulation is this will allow the FDA to go after the other companies like OSIRIS who are clearly stretching the 361 process. Osiris is injecting live cells into their product which is a blatant violation. The key why I think this is the way the FDA will go is MIMEDX has had 2 visits from the FDA and has passed with flying colors and if you go on the website you will see the posted letters from the FDA stating the NAI's. "NO ACTION INDICATED" Oh an important peice is the last NAI posted was 14 months ago which is another reason why I think this scenario is plausible.
Scenario #2 is the FDA has a problem with the labeling of the product. Mimedx goes on the website and we re-label. No problem
Scenario #3 is Mimedx cannot convince the FDA that their process is not manipulation. The Amnio Fix is a drug. Now the company would have to apply for the BLA "Biological Liscence Agreement". Not a big deal, it would cost the company approximately 1.5 mil and Mimedx already has tons of DATA because don't forget they have sold 18,000 ogf these units. In addition the key is Mimedx would still be selling the product while conducting the BLA. By the way AXOGEN had to go this route. They continued to sell their product all the way through the BLA. So we now have a comparison.