Bioelectronics Corp (BIEL)

[Vapor09]

I’ve discussed this with someone who owns a medical device company and deals with these submissions daily. It 60 days with approval, or greater than 60 days with questions and the timeline resets with every separate set of questions.

FDA questions are not bad, but if the company does not communicate that questions have been asked, we can only assume that the 510k was kicked back with no approval.

I anticipate approval...