Bioelectronics Corp (BIEL)

[uksausage]

does anyone know if the knee study showed any bias as to the left or right knee?

can't help think the FDA has just thought of a reason t o deny out of thin air. Is there a check box for gender in the application form?

did the data for other studies actually have gender recorded?

Can't imagine how to market a back pain solution just for women, the public will think they are crazy.

Should have been cleared but with some strict labelling requirements which would state that "this product has been shown to work better for women, men benefitted but to a lesser degree" or something similar.

thats what labelling is for.

but because the predicate studies didn't show any deviation they cant be used.. that is complete FDA obstructionism and their senators should get involved.