Bioelectronics Corp (BIEL)

[uksausage]

the May 9th meeting is to discuss the best way forward for them to get approval and for what.
Their original application was made before the changes to rules that allowed Real world Data to be submitted and so their study for back pain wasn't allowed and hence only knee and foot pain were covered.

there is an argument that says they can submit the back pain trial against that application for speedy approval (or rejection), but there may be benefits for a fresh 501K submission specifically for the general pain classification

The meeting on May 9th should end up with everyone agreeing on the speediest and most likely route to getting that general clearance. They then have to make the actual submissions and wait and wait and wait (but it should be easier than before since we know what category to use and have a number of referenced products