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Re: BuddyGuise post# 184415

Monday, 02/15/2016 10:28:11 PM

Monday, February 15, 2016 10:28:11 PM

Post# of 446629
FDA approval coming soon:

Successful formulation/technology: COMPLETE

Pivotal BE Study: COMPLETE

Registration Batches: 6- mos ACC, 24- mos CRT: COMPLETE

Lab Abuse Study: COMPLETE

Liking Study, Intranasal: COMPLETE

Fed Study: Dosing COMPLETE

Withdrawal Study: Dosing COMPLETE

Efficacy Study: Dosing COMPLETE

Pediatric Study: Post product launch

FDA Filing Fee: Waived

Elite's First Art NDA Filing- ELI 200: COMPLETE

FDA NDA Acceptance: Imminent

NDA Expedited Review: Imminent

Two Generic launches: Imminent

Guidance for ELI-201 and 202: Imminent

SequestOx Launch: Scheduled for 2016

FDA encouraging the development of, abuse-deterrent formulations of opioid products

You Can Tell A Man's Character By The Way He Treats Those Who Can Do Nothing For Him

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