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Re: nybuild1 post# 40888

Wednesday, 04/13/2011 12:33:45 PM

Wednesday, April 13, 2011 12:33:45 PM

Post# of 59551
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!!

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