Great news for IPCI! We could get to market before ELTP...less competition!
Looking at the timelines for ELTP news releases:
- Jan. 13, 2016 -- Elite submitted 505(b)(2) NDA for its lead opioid abuse-deterrent candidate ELI-200, immediate-release Oxycodone.
- March 17, 2016 -- Elite announced NDA for SequestOXTM (ELI-200) has been accepted and granted priority review by the FDA. The FDA has set a target action date under the PDUFA of July 14, 2016.
- July 15, 2016 -- Elite announced that the FDA has issued a Complete Response Letter (the "CRL") regarding the NDA for SequestOx™.
What I find interesting here is that the review time was targeted at 4 months for a priority review by the FDA after the NDA was accepted. Perhaps this is because the Elite NDA was a 505(b)(2) review? A 505(b)(2) relies on a previously approved product that was submitted with a standard NDA. That is, the FDA doesn't have to review new clinical trials and biochemistry of Oxycodone, just the bioequivalence studies conducted by IPCI. Much less work for the FDA to review.
The good news is that Rexista will be filed under the same 505(b)(2) pathway, so if we get a priority review, we may get the same 4 month review cycle! This would put the PDUFA date at approximately February 1 (not the April 1 I mentioned in my previous post).
Questions for IPCI management: do we expect a priority review after the NDA is accepted? Will this be a 4-month review?
