morgans - eps 74.5c/share by fy2016!, page-12

Thought I might join this thread and provide a more complete response to frankshie's question.

....

The reason/s why QRX was issued with a Complete Response Letter from the FDA following their initial submission can be found in an ASX Release dated 20 August 2012. According to this information:

"The FDA requested further information regarding data filed as part of the MOXDUO New Drug Application (NDA) and additional analysis of trials completed to date, including Study 022 which evaluated oxygen desaturation levels in patients receiving MOXDUO compared to those administered morphine or oxycodone alone at equi-analgesic doses. Oxygen desaturation is a medically important adverse event and a leading cause of death from high doses of opioids.
“We were encouraged by our reception at the FDA; the Agency confirmed our Combination Rule Study (Study 008) satisfied efficacy requirements and there were no unexpected or problematic safety issues in any of the studies submitted as part of the MOXDUO NDA,” said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. “Additionally, at the FDA’s invitation, we agreed to submit more extensive information on Study 022 and believe the results of this study provide further safety data to support approval of MOXDUO.”
Analysis of Study 022 was completed after the MOXDUO NDA filing in August 2011, although early safety data were included in the 120-day update filed last December. Accordingly, additional efficacy and safety information from this study was of significant interest to the FDA."

In short, it appears that the FDA wanted the full results and analysis of the Oxygen Desaturation Study 022.

As T_N pointed out, the most recent delays with the NDA were due to one of the test sites in the USA not adjusting the clocks on their recording equipment to account for regional timezone changes and daylight savings changes. This error was reportedly detected by QRX staff in their preparation for the Advisory Committee Meeting that was scheduled for 17 July, 6 weeks prior to their scheduled PDUFA date on 26 August. On finding this error, QRX requested that their scheduled AdCom Meeting and PDUFA dates be postponed by the FDA so they could perform the necessary re-analysis and correction of Study 022. On reporting this error to the FDA, the FDA requested that QRX re-analyse Study 022 in its entirety, not just the affected data (15-20% of the data-set). As this re-analysis could not be performed by the already scheduled PDUFA date of 26 August, the FDA had no choice but to issue QRX another Complete Response Letter requesting that they resubmit their NDA. The NDA was resubmitted last week (i.e. 26 November) and the new PDUFA date will be announced in the next week or two and should fall in late May.

That leaves us where we are now.

This time around, then, the NDA will contain the fully-analysed data and results of the Oxygen Desaturation Study (Study 022) which were not included in the initial submission. IMO, given that respiratory depression is the most fatal of all opioid side effects, QRX is now in a far better position to receive approval for MoxDuo IR.