Vivos Inc (RDGL)

[DTGoody]

I hope this puts the timeline issue to rest. I don't know how to do this linking deal, so I hope it works. Below is an FDA attachment showing the "120 calendar days" timeline for De Novo applications. The link below that is for an article I found that explains the newly revised De Novo approval process. The bottom line is that the 120 days are not written in stone, regardless of whether or not the FDA seeks clarification. Some De Novo applications take longer than 120 days and some take shorter, so in conclusion - the De Novo decision could come at any time, but that time could be WHENEVER.

http://investorshub.advfn.com/uimage/uploads/2015/5/14/oypgpDe_Novo.jpg

http://www.mpo-mag.com/issues/2014-10-01/view_columns/fdas-revised-guidance-provides-update-on-direct-de-novo-pathway/