re: Ann: Chairman and Managing Director Addre... Extract from...

re: Ann: Chairman and Managing Director Addre... Extract from QRX Chairman Dr. Peter Farrell.
Quote: "......At the time of last year’s AGM we had recently submitted our New Drug Application (NDA) for
immediate release MOXDUO – our first pain drug candidate. This was a significant milestone
for the Company and the culmination of excellent clinical trial results; along with drive and
commitment from the team who had worked extremely hard in the four years since our IPO to
deliver this crucial milestone.
In June this year we received the disappointing news that the United States Food and Drug
Administration (FDA) had issued a Complete Response Letter (CRL), advising that we were not
successful with our initial NDA filing in obtaining FDA approval for MOXDUO.
While this turn of events took the Company’s board and management – and shareholders – by
surprise, we have since been encouraged by the outcomes of our subsequent dialogue with the
FDA.
At a post-submission review meeting with the FDA in August 2012 the steps needed for
approval were clarified. Importantly, it was confirmed at this meeting that there were no
unexpected or problematic safety issues in any of the studies submitted as part of the MOXDUO
NDA.
The FDA has requested further information regarding data filed as part of the MOXDUO NDA
and additional analysis of trials completed to date, which were targeted to meet requirements for
approvals in Europe and Australia. Of particular interest to the FDA were the results from Study
022, a study that compared respiratory depression for MOXDUO versus single equi-analgesic
doses of morphine and oxycodone. This study indicated that MOXDUO resulted in less severe
respiratory depression than either morphine or oxycodone given separately.
The next step for the Company is to refile its NDA with the additional data to address the FDA’s
requests, which we believe could result in a positive decision from the FDA during 2013.
Based on the dialogue that has taken place with the FDA, as part of this process, the Board and I
remain confident that MOXDUO will receive approval. There is a strong precedent with drugs
which receive a CRL response in the first instance and then go on to obtain approval.........." end of quote.

It is a confident statement and he last sentence straight out bullish.

Will QRX bulls muster and bears head for the cave?