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Monday, August 01, 2016 12:57:25 PM
FDA at least 3 times has rejected that route and said they need to go the PMA route.
PMA is multiple times more expensive and require clinical trials, none of which IGNG can afford While still in bankruptcy and in default on their bankruptcy payments
It is a ruse to raise funds, They can find somebody, anybody to "submit" something to the FDA, but it is not a PMA and the FDA has repeatedly said this device cannot be submittted as a 510k.
Read the SEC charges against Dean. That's one of the things they emphasized.
#1). You have money. Other people want it. All of it!
#2). You want easy money. So does everybody else. They'll get it, too....yours! (and all of it!)
#3). You tell yourself you're smart. You won't lose your money. Fact: Other people are smarter,
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