Replies to post #14353 on Bioelectronics Corp (BIEL)

[imrichbeotch]

Yea it sucks. If they dont get clearance this month I may be out.

[uksausage]

Today is the anniversary of the DeNovo application for Allay - Actipatch followed later.

Given they are creating a brand new category of device here, along with the obsessive nature of the FDA I am not surprised it has taken this long but it should be getting clearance soon.

Remember there on average only 6 DeNovo applications cleared per year. This isn't like 501(k) and other processes.

The more detail they have the narrower the definition which will stop others trying to get clearance on the back of BIEL.

The last we heard there were more bench test results waiting to be submitted which they claim to have been doing after getting their latest patent filed. If related it must be to do with heat/operating conditions of the device.

Would be nice to have an Anniversary update