In relation to the concerns over Zohydro and what that may mean...

In relation to the concerns over Zohydro and what that may mean for the approval of Moxduo, it is important to realise that Zohydro ER is an "Extended Release" opioid while Moxduo IR is an "Immediate Release" opioid. The FDA's emphasis on opioid abuse deterrent technology (ADT) is directed toward Extended or Controlled Release opioids like Zohydro, not Immediate Release opioids like Moxduo IR. For this reason, QRxPharma has developed Stealth Beadlets for Moxduo CR, which is currently in the development pipeline and not yet up for FDA approval. In the internet-televised and FDA-monitored investor call that followed the last Complete Response Letter, QRx CEO Dr John Holaday confirmed that the FDA does not require ADT for Moxduo IR, so this should not be an issue.

For information regarding the FDA's concerns over Extended or Controlled Release opioids, see the folowing document:

http://www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass/ucm277916.pdf

Good luck to QRx and all holders.