Bioelectronics Corp (BIEL)

[art2426]

At this point in time the past rejection letters are irrelevant in any new decision to be made by FDA. With the new category being created, a new 510k will have to be submitted and the education learned from these rejections hopefully will be used to conform to the FDA way of thinking. Many initial rejections from various companies submitting to the FDA have been used as a framework for what is to be needed for acceptance. ITS context, hopefully learned and adjusted from previous filing, will be the deciding factor and NEW basis for FDA acceptance or rejection. I am pretty sure we can all agree that this decision of "new category" gives Bioelectronics and all other companies in this field a second chance to prove its worth. Hopefully they have all learned from their previous attempts.