good value @ current level, page-2

Excellent points you have highlighted there and I wholeheartedly agree that QRX is good value at the current price.

Given the FDA has already affirmed that "the safety and efficacy of MOXDUO are not at question", I can't imagine why they will not go on to ultimately approve it.

Surely, if they are satisfied that the clinical trials have demonstrated the safety and efficacy of Moxduo, then they should be satisfied that these same clinical trials have also demonstrated that Moxduo significantly reduces the most common side effects associated with opioid use.

Even without the significant reduction in respiratory depression purportedly evidenced by Study 022, I would imagine that the reductions in nausea, vomiting, dizziness, itchiness, headache, and drowsiness should be enough to secure its approval.

QRX appears to have shared this view, as their initial NDA was filed without the inclusion of Study 022 (see ASX Announcement dated 20 Aug 2012).

In fact, Study 022 was completed subsequent to their initial filing so that the original NDA included only "early safety data" which were filed in a "120-day update".

Given that respiratory depression is the single most harmful side effect of opioid use, it is little wonder that the FDA withheld their approval last June so that they could see the fully analysed results of Study 022.

This time round, with Study 022 fully complete and rigorously checked (as a result of those costly time-keeping errors), I am betting that Moxduo will get over the line.

Even if it doesn't, I'm betting that the SP will rise back over the $1 mark prior to the (forthcoming) PDUFA date.

Either way, I believe QRX is currently an excellent buy and, aside from fear and panic - and perhaps a little short-selling and day-trading - I can't imagine why anyone would sell at this price.

As your Warren Buffett quote implores:

BE FEARFUL WHEN OTHERS ARE GREEDY...
AND GREEDY WHEN OTHERS ARE FEARFUL

As always, however, DYOR and be responsible for your own decisions.