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tangerine

11/13/14 12:15 PM

#134135 RE: dr_lowenstein #134133

Maybe because these are different concepts, one with embedding a bead inside a bigger bead. You know the one that been approved so many times but gets recalled and retested because they can't seem to get a stable batch or some other odd reason....and still no launch

What is there to learn from running efficacy trials on a multi bead system? And no one had come up with any reason why Elite would obviously not pass any efficacy trials if they were needed. It is a generic drug. The Naltrexone has already been proven to be sequestered in the current trials. Opioid generics relieve pain and based on blood plasma it is being released at the same rates as the reference drug.

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NASDAQ2020

11/13/14 2:40 PM

#134163 RE: dr_lowenstein #134133

You can only invent the wheel once. Camargo is taking the 505 route with the FDA.
FDA likes the pharalogical approach to abuse resistance.
FDA had a huge 2 day meeting with BIG pharma last month in Maryland.
They drove this point home. Glad to be in on the bottom floor. GL