In its recent press release the company stated as follows:
"Elite will immediately submit a 505(b)(2) New Drug Application for its lead opioid abuse-deterrent candidate ELI-200, immediate-release Oxycodone Hydrochloride 5mg, 10mg, 15 mg, 20 mg and 30mg capsules with sequestered Naltrexone Hydrochloride, for the treatment of moderate to severe pain with the United States Food and Drug Administration. FDA notification regarding acceptance of the submission for review is expected to take 6 to 12 weeks."
It was my understanding based upon the last conference call that FDA notification regarding acceptance of the submission was only a 30 day process. In that call I recall the submission was to occur in December and we'd be notified in early January.
On that basis I am assuming the application is not being submitted "immediately"and there is going to be at least a 2 month delay in submitting the application. I'd speculate as to the reasons for the delay but that would be folly. Or Did I misunderstand that the notification of acceptance was a 30 day process after submission
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