Fred's responseHaving just read the FDA Gov website as suggested by Gunner, I think we are moving along the expedited path. I believe the FDA had some outstanding questions and got back to Prometic by day 60 (calender) days. Prometic responded to those questions and we are now waiting to hear from the FDA. This is basically what Fred said in his lastest corresponence with this board. The FDA could have said Yes, it's a go or No we don't have our questions ready for you so we will get back by day 74 latest or as I said above the FDA sent us their questions within 60 calander days. I must admit the whole process is complicated but I suppose in the end effective....