Replies to post #214760 on Bioelectronics Corp (BIEL)

[dr_lowenstein]

Yes I do

[Probity]

>> The implication by another poster was that ActiPatch is an inferior product because it chose to gain Market Access through the 510k Process. <<


The implication is two-fold. One implies that the product has gone through in inferior PROCESS. And two, by implication, that it is therefore an inferior product.

A load of nonsense given the predicate device.

[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.

[markjohn62]

The claim that a clearance is inferior doesn't even matter. The FDA clearance allows ActiPatch to be sold OTC and be marketed toward ALL joint/muscular pain. It got us what we want. Now we just need a partner to sell it.