I agree rgc68. Personally, I thought this status overview was a...

I agree rgc68. Personally, I thought this status overview was a lot of nonsense. The idea that investors should reach into their pockets for another c.$50m and wait around a few years for QRX to pull a rabbit out of a hat is laughable - imo. To get a more balanced view of this I commend to you the minutes of the FDA meeting and the FDA staff presentation which is now available at:

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ucm390304.htm

You will see this quote on p.5
"The position of the committee was summarized by the Chair, in reiterating the committee’s lack of confidence with any clinically meaningful safety difference, combined with the consensus from the sponsor and the agency that there is no notable efficacy difference. Given this lack of efficacy benefit and uncertain safety benefit, the Chair stated that there is “no basis for approval.”

So it is now beyond argument that Moxduo has no efficacy advantage. Many millions of dollars of shareholders funds have been burnt up proving that point. Also, if you read the minutes you will see that there was no consensus view as to the paramaters or objectives for further tests to establish any relevant safety advantage. In fact there were conflicting views about this.

You should add into this mix comments by the FDA Commissioner in a separate speech (coincidentally on the same day as the AdCom meeting) which demonstrates the politicisation of the opioid issue and the FDAs reluctance to grant approval for any new opioid unless there is an "important safety benefit". Relevantly, you will see from the Commissioner's speech that she seems to have agreed with the philosophical position adopted by the FDA staff in the Moxduo review (despite the contrary views of QRX which leaves me with the impression that this was all a bit above the FDA staff pay scale). You really have to read the whole speech but it left no doubt in my mind that QRX has completely misread things...and continues to do so.

The speech by Dr Margaret A. Hamburg, Commissioner of Food and Drugs can be found at:

http://www.fda.gov/newsevents/speeches/ucm394400.htm