opening briefing- dr. john holaday, page-2

Long recording. Personally I loved the analyst who asked what their anticipated capital requirements were for the next 5 years!

Takeaway points for me were:

- QRX were pleased with the meeting, as they feel the additional data from #022 not included in the initial application may be suitable to address the FDA concerns.

- They will submit their minutes of the meeting to the FDA in coming weeks, and anticipate the FDA to provide their minutes of the meeting to them in approximately 30 days (ie late September).

- They provided some additional data at FDA meeting, but upon reviewing FDA minutes will be able to confirm what additional data to submit.

- They anticipate refiling later this year, with hopes for approval mid-2013.

- They do not anticipate a requirement for any further clinical study before resubmission, therefore reaffirmed guidance that on this basis, they have sufficient capital through to end of 2013 (ie to facilitate product launch).

IMO a positive briefing; please correct where I may have made any mistakes.

Roboshan (who appears to have comprehensive knowledge of FDA approval process) from what I gather raised a very good point previously IMO re product safety vs sales. Even with FDA approval, they will need to convince clinicians in pain management of the advantage of Moxduo vs conventional single opioid treatment (ie, morphine or oxycodone).

IMO this is a worthwhile area of discussion, as that process will be key for QRX / Activis to unlock revenue within that potential market. FDA approval just gives them the opportunity to launch and commence that marketing process.

Thoughts?