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Monday, December 21, 2015 12:55:28 AM
Not too hard to add it all up with all these pieces to the puzzle.
Radiogel "CAN" be submitted to the fda via denovo with no human testing. It will be denied again gauranteed.
If radiogel ever has a chance of getting fda approval it would have to have human testing. Its a no brainer. There's no predicate device like the other y90 products so even if some of those didn't need clinical trials this will.
With all the smoke and mirrors going on and jim wording EVERYTHING like a lawyer and beyond vague the pieces to the puzzle all fit together. A state agency listed the fda wants human clinical trials.
The writing is on the wall.
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