NEPH will get a chance to resolve the issues through either a clinical trial or revisions to the device and new data as part of the PMA process. A device can be ruled NSE but can always be resubmitted based on feedback received from the FDA. Money and ROI becomes the limiting factor. That of course is the primary fear with IMGG. The process drags out for years, further dilution occurs and eventually the bank runs dry. NEPH is cash poor at this point and will have to take on a partner to run the next leg of the race. Here's to hoping we don't experience the same.........