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Dr. Mugs

04/13/11 11:30 AM

#40889 RE: nybuild1 #40888

For some reason, I can't watch the money TV either.. It always just makes me want to throw up!! There is no such thing as a 3 step protocol for a 510k submission. That is why there has not been an 8K filed regarding this process. He would not tell this nonsense to the SEC because he is making it up! Dean Janes is just a hair coloring, pizza eating ,huckster, clown, lyer and it is foolish to hang on to anything that comes out of his mouth because it is all just a bunch of dog do! He needs to be in hancuffs or a straight jacket... He is one lying nut job!!
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Boxsterfan

04/13/11 12:33 PM

#40894 RE: nybuild1 #40888

We are at step 1 of a PMA. Dean Janes the carnival barker claimed that he was still 510K, but a PR will come out in the next 60 days stating the FDA has made soem sort of "final determination" of PMA. Just think...after 5 months of stalling, he is just now trying to schedule meetings with the FDA which takes a max of 30 days (by law with written request).

Of course, we already knew this PMA when the device was REJECTED by the FDA and went Class III per the letter as is standard "protocol" (a new favorite word by Dean Janes, the baby money stealing con artist). Of course, if you understand the FDA you will know that "protocol" means "trials" which means PMA. Dean, the penny stock CEO, could at best get into a "phased PMA" but a PMA is a PMA and these things costs money and take lots and lots and lots and lots and lots and lots and lots of time. Dilution straight ahead. 1,000,000% GUARANTEED!!