As a point of order the FDA operates on a 90 day schedule. However, you are counting business days to include holidays. If you take into account that there were a total of 5 holidays on the Federal calendar you will come to the realization that February 10th is the target date for the 510K to either be approved for immediate distribution or for the FDA to request additional information. It is my understanding that the company provided additional information in January and that this information was minor with respect to the overall filing. Given the FDA's latest brachytherapy device approvals, I see this as a very positive sign for ADMD shareholders in the short term.
The filing was completed on November 3, 2013. The FDA has 90 days to respond if they have any questions regarding our application and if it should be ammended in anyway. We have not been notified of any exceptions so far and now it is a waiting game. There is no defininte date, but we are eagerly anticipating a response by the end of February 2014.
As this is a material change in our company, once we receive approval the investing public will know immediately.
Thank you for your interest and support in our company.
THIS LOOKS VERY POSITIVE TO ME. Let me know what you think