Bioelectronics Corp (BIEL)

[Hinsk]

It is not an inferior product, the FDA allows for the two different types of submissions. It is FDA cleared. They can not say FDA approved in packaging that is a legal fact but it does not mean it is an inferior product. The data in the submission has to be substantially better than a previously approved FDA product. The FDA has to come to the the conclusion that is it substantially better. The FDA DOES NOT give clearance or approval for innovation alone Or to snake oil, gizmos or junk. Biel’s submission meet the requirements of the 510k it was a faster clearance to market. The clearance will allow for partnerships and so on. So long story short clearance can be and is a good thing.