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NASDAQ2020

06/06/16 2:55 PM

#203230 RE: Hike #203228

This weeks ADCOMs appear to be raising the value of Elites ADFormulation.
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NASDAQ2020

06/06/16 2:57 PM

#203231 RE: Hike #203228

Nice DD. thx
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toofun

06/06/16 3:29 PM

#203243 RE: Hike #203228

Thank you, Yes now I remember from awhile ago. Could our little company actually be holding the Holy Grail?
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kayak_wench

06/06/16 3:53 PM

#203249 RE: Hike #203228

Hike that didn't address whether they tested solvents after crushing. When I first saw that slide I read them as stand alone tests (i.e. solvents on intact beads trying to find way to remove covering over one and not the other). I'm not too concerned because they will approve many drugs as ADF as they wait for the Holy Grail....if it can even be attained.
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toofun

06/06/16 6:01 PM

#203259 RE: Hike #203228

After reviewing the FDA's Industry Guidance document

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm334743.pdf

Category I includes the product having been manipulated. Therefore, I chose to read the slide as having been worded too succinctly in not making that clear.