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Thursday, May 05, 2016 10:28:51 PM
In contrast, this is what the drug liking curve looks like for what will be the first-ever immediate-release opioid to receive Category II ADF label.
Did I mention that ELTP 2 bead pharma-based ADF is modular across every agonist and time-release characteristic? Are you starting to understand what I mean when I say The Golden Ticket? They aren't just giving these ADF labels away. And when SequestOx is approved with ADF label, FDA is on record saying that there will be no new generic oxycodone approved without ADF and all existing oxycodone ANDA's are on notice that they could be pulled unless they acquire equivalent ADF. Did I mention ELTP 2 bead pharma-based ADF is fully-licensable?
What happens when PuraCap Pharmaceuticals voluntarily adds ADF to their oxycodone ANDA by utilizing ELTP 2 bead pharma-based ADF? Then there would be 2 immediate-release oxycodone ADF. Add a hardshell ADF and gooey ADF and pretty soon you've got the makings of a non-ADF generic oxy flush-out.
Now repeat with immediate-release hydrocodone, morphine, hydromorphone. It's too easy. I'd license out the 12 & 24 hours products and pile up the quick & dirty (and cheap) immediate-release NDA's. (One caveat being there is not currently stand alone hydrocodone IR, only combos with acetaminophen,etc. so no 505b2 on that one.)
"There are three kinds of lies: lies, damned lies, and statistics."
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