This seems ass backwards. So, show me you can mass produce, distribute and market and THEN we will consider it for approval. If this is true then only major players can enter this market. All the more important it is for the the company to find the right large scale partner to license or sell out to. If the company can have Dr Faro get in front of the right decision marker to present our product this can get done. They are saying if you can't mass produce no need to apply. Confident this will get done. It will be a win, win. I feel we are in the final stage. imo