re: Ann: Path Forward For Resubmission of MOX... Leveller,the...

re: Ann: Path Forward For Resubmission of MOX... Leveller,the FDA is doing a lot of "head-scrathing", as JH has referred to it. In my opinion they are just incompetent and underfunded. Referral to an Advisory Committee was initiated by the FDA as they have never ruled on an NDA, where the combination drug, under a combination rule, includes two drugs from the same drug category (Opioid). In a nutshell, the FDA have no idea how to approve such a therapy. There is no precedent.

I have absolutely no connection to medicine other than my brother who is a paediatrician. However, under the combination rule QRX have fulfiled the FDA requirement. This means the drug is approved. However the reality is that is isnt.

Submitting under the combo-rule was made necessary in '70s (I think) as the industry found that a lot of drugs were capable of being crushed up, and generally tampered with before being consumed. The method opened the window for abuse - like boiling powder in a spoon. The industry recognised that the process for approval against combo-drugs needed an overhaul, and hence the rule i.e show superiority of 'combination'

In my mind the ONLY element that hasnt been proved under the current approval process is the potential for abuse. In saying this the FDA has not defined the requirement to show non-abuse. This may be an area that the committee looks at. There is nothing QRX has not covered in terms of NDA submission. If you speak to JH/QRX they go on and on about the number of data points, variations of tests and statistical results. They have left no rock unturned. In fact the company has to some extent anticipated the FDA moves by 'designing-in' an abuse proof deterrent. This is part of the CR formulation. Unfortunately this is not part of the current or should I say resubmission of the current NDA, for reasons I previously mentioned (not a requirement).

Its possible that IR is knocked back, but CR will be approved, however the company doesnt believe this is a likely outcome.

My strategy has been to wait and see, regardless of interim milestones eg: NDA filing etc. In Oct (or around that) I will buy a small holding and accumulate if approved all the way to $2 if i have too. The market size supports this. If non-approval I will participate in the CR which will have to be done to continue with any further studies or submission of other products in the pipeline (non-IR), but I will only be exposed by the small holding and subsequebnt participation. There are always two sides to the argument because if you buy now, its early, cheap and you take on all the risk. But if all goes to plan you'll make more money than I will; classic risk return.

Just throwing some ideas out there.