where is the love for qrx?

Given (1) the science behind this stock, (2) the reasons for its delays in the FDA approval process, (3) the positive tone of the recent review meeting with the FDA, and (4) the bullish valuations of this stock by such analysts as Citi, I am surprised that this stock has hit and remained at such low levels recently.

Of course, its prosperity is inextricably linked to the FDA's decision on its soon-to-be-refiled New Drug Application for Moxduo-IR.

I, for one, am confident that the FDA will give it the green light.

If you are holding or considering buying this stock but want to get some idea of the likelihood of the FDA approving it, you may find the following Reuters article of interest:

http://www.reuters.com/article/2011/02/14/us-pharmaceuticals-success-idUSTRE71D2U920110214

According to this article, during the period from 2004 to 2010, the success rates for new drugs navigating the FDA clinical trials and approval process were as follows:

- Overall, only about 10% made it from early Stage 1 trials to FDA approval
- 63% passed from Stage 1 to Stage 2 trials
- 33% of these then passed from Stage 2 to Stage 3 trials
- 55% of these went from Stage 3 to lodging NDAs (application costs over $1M USD)
- 80% of these NDAs eventually got approved, though only "about half" were approved on their initial application

Based on these stats, at this stage of the process, QRx has a roughly 67% percent chance of getting approval for Moxduo-IR.

These are pretty good odds in my opinion, especially when we are told that, in its recent review of QRx's application, "The FDA reaffirmed that the safety and efficacy of MOXDUO are not at question" and "Accordingly, the FDA encouraged QRxPharma to submit its validated data and updated NDA" (see the ASX release dated 9 Oct).

IMO, these odds are further bolstered by the fact that Moxduo is a combination drug that evidently significantly reduces the side-effects of its two well-known and commonly used components (Morphine and Oxycodone).

Thoughts anyone?