Bioelectronics Corp (BIEL)

[uksausage]

If I were to guess this could be due to the final order being significantly different to the proposed order. Hence a meeting to explain that prior to issuing the final order.

IMHO they are going to make the final order enabling OTC immediately not through special processes, just straight 501k submissions with special conditions (labeling).

there was no evidence submitted justifying keeping any of the devices in this category as prescription only devices.

They may want them to be OTC but not "on the shelves" like some items are but anything that puts the public closer to getting their hands on Actipatch in the USA the better.