Replies to post #32473 on Bioelectronics Corp (BIEL)

[zemun10]

The FDA released it yesterday. Do your research before write something that is not true. I know about it since yesterday morning.

[uksausage]

you are confused

the FDA have re-categorized all these types of equipment to class II with special conditions.

Each device manufacturer now has to re-submit a n application to be classified as SWT equipment and hence ear class II categorization.

It is a major change by the FDA.

Can BIEL now sell OTC - no
Will they be able to when they submit their paper work - almost certainly yes.
How long will that take? may be 6-12 months unless there is a fast track system after this reclassification.

but it opens them up to buy out IMHO.