re: Ann: Path Forward For Resubmission of MOX... Can I just...

re: Ann: Path Forward For Resubmission of MOX... Can I just proffer another opinion which is an extention of my last post. With reference to this:

"The FDA also voiced for the first time that no precedent exists for their review of combination products where two drugs in the same category are combined (e.g. morphine and oxycodone as “opioids”). Therefore, despite the Agency previously confirming that there were no safety issues in any of the studies that were part of the original NDA, the resubmitted application, including new results from Study 022, will likely undergo review by an Advisory Committee in late Q2 2013. The Advisory Committee will evaluate the approvability of MOXDUO in the management of acute pain. The reliance on Advisory Committees has been made more common or compulsory since the FDA Amendments Act of 2007."

There exists a precedent for '2nd round review' or review via the 'advisory committee' in terms of average reportable timeframes. However, as noted by QRX and in turn FDA there is no clear precedent for this type of drug/therapy.

Again I have no interest in this stock other than an observer (which is proabbly an interest). But, I would say that my counter-parts are looking at this detail now to determine potential impacts. This is something that is out of QRX's control, and is an example of FDA red-tape and bad practices as I have mentioned. MOXDUO as a combination-opioid was known when NDA was first submitted. A path forward should have been assessed and communicated then (if not approval). But no - 6mths later we get an update.