FDA Plays

[Guy]

QRXPY (3.94) - PDUFA date of 25 May 2014 for action on the Company's refiled New Drug Application for immediate release MOXDUO. The FDA will schedule an Advisory Committee meeting prior to this date (sometime in April).

http://qrxpharma.com/go.cfm?do=Page.View&pid=19

"Pending US approval, we are well prepared and poised to launch MOXDUO in the US with Actavis. Actavis' proven track record in the launching and marketing of opioid products will facilitate rapid uptake and significant sales in the US and maximize value for our shareholders."

"The FDA previously confirmed that the Company’s Combination Rule Trial, Study 008, satisfied efficacy requirements and that there were no efficacy or safety issues identified in any of the studies submitted in the original NDA"

http://qrxpharma.com/download/file/filings/2013/QRxPharma_Resubmits_MoxDuo_IR_NDA_Nov_2013_Final.pdf

March presentation:
http://qrxpharma.com/download/file/cp/QRxPharma_Investor_Deck_March_2014_Final_%2814_March_2014%29.pdf