Vivos Inc (RDGL)

[archie09]

The company has not and will not file for RE CLASSIFICATION...Jim Katzaroff is a "MAGICIAN" with words...according to Katzaroff the FDA said NO, but really didn't mean NO if we can work it out through working with the FDA, unless it is easier to reclassify..READ THE FIRST PARAGRAPH BELOW..IT IS THE LITERARY EQUIVALENT TO A DOG CHASING ITS TAIL...the second paragraph was a little "BAIT" for unsuspecting investors..Katzaroff having failed with his FLAGSHIP product, sets out hope for another product and how it will be in production soon and what a bunch of BULL!....and in the latest quarterly, KATZAROFF comes clean and says he will need 5 million dollars and 2 years to even get anywhere close to production...for a PRODUCT THAT HASNT EVEN BEEN REFILED FOR APPROVAL FOR 8 MONTHS NOW!...what a disgrace...................................................... The FDA, which previously advised AMIC that it would review the product as a medical device, has further advised AMIC that it has determined that the product is classified by statute as a Class III medical device, unless the device is reclassified. The Company intends to work with the FDA to seek such reclassification, unless the additional steps required for approval of this product as a Class III medical device are more efficient. The Company has obtained input from the FDA regarding its alternatives and will seek further input to expedite the process.

The Company intends to shortly file for FDA clearance or approval for one related Yttrium-90 brachytherapy device and after receipt of substantive responses from the FDA to that application, file for clearance or approval for a third product.