Replies to post #20341 on Bioelectronics Corp (BIEL)

[fuente]

Simpson - There is always discussion back and forth between firms with respect to label claims, particularly for new products. I would assume this is/will/did happen with BIEL, and that the wording around the indications for use, claims, and safety are all consistent with not only the clinical trial data but the expectations of FDA, moreso because this is a new class of product as well.

In the end, you do what FDA tells you to do..if you want your product cleared/approved, that is. It's not so much of a negotiation as it is a mandate. After all, the clinical data must scientifically support the label claims.