Bioelectronics Corp (BIEL)

[Vapor09]

Unfortunately, I do not believe we can determine timing of FDA approval any longer. We have gone beyond 60 days, and although the 90 day mark is still out there, I do not believe it applies to this 510k. With the email I received from BIEL that FDA has asked questions, the 60 day clock I believe applies was rest between 11-14 Sep based on an interview prior to my email that said no questions had been released. Who knows...? BIEL, and we will just have to sit and wait.