palms are sweaty, page-28

Hello All,


I am a long time reader, first time poster on HC. Having read both the FDA Submission and QRX's Submission, it is quite clear the cordial history between the two is not clear cut. Underpinning several inconsistencies between both parties accounts of the story.

The FDA's slant clearly focuses on Nausea, Vomiting and Dizziness as its basis for disagreeing that MoxDuo has a safety benefit whilst only briefly touching on Oxygen Desaturation as an afterthought. Very minutely identifying the fact that there are clear safety benefits for key demographs (Smokers, elderly, obese, etc.) and key serious events associated with using Opioid's in the treatment of Acute Pain (i.e. Severe Desaturation below 85% onwards).

However, QRX's submission should have focused a bit more on why the incidences of Nausea, Vomiting and Dizziness were comparable to Morphine and Oxycodone. On the preponderance of information available, I still do believe that MoxDuo has considerably efficacy, titration scalability and a safety benefit to warrant conditional approval as a Schedule 2 drug.

The people who have the most to answer for is invariably the FDA then QRX. At absolutely no point in any of their or QRX's correspondence have they EVER suggested the need for further clinical studies and then wait until this point to suggest it as a question is EXTREMELY convenient by their standing. Coupled to this, QRX has to explain despite their "Cordial" relationship to put in the CEO's terms, why key elements of their engagement with the FDA were either downplayed or casted as irrelevant.

As a loyal (and considerably pissed off) shareholder for 6 long years, I fully intend to sit in the webcast of the committee and put forward the hard questions to the executive in the conference call and ensure that they do not take my loyalty for granted and restore vital credibility.


Kind Regards,


chihiro873

- "To thine ownself, be true"