Bioelectronics Corp (BIEL)

[uksausage]

art was suggesting in his post that full clearance was just a matter of time.

I think we have to actually apply for it with a fresh 501k and new data or at least using the new rules about RWD and the survey data we submitted last time.

the clearance we have is limited - no retail pharmacy is going to sell on their shelves if it isn't clear how to stop people from using on the back or other body parts - in this respect the smart insole should be selling by now. Likewise McKesson or others aren't going to take over the marketing while it is still restricted as to what you can say.

They have had 8 months now so I suspect they are close to a compromise and the new sales director seems to have the energy and real world experience to wake Andy up!