Posted:
#1
As many of you know, I am long POZN as I was when they received their 2nd approvable letter on August 2nd. It's been a rough ride but I have added to my position in the high 8's and have recently added a 35 contract position in the January 15's at .30.
It appears based on today's news that the company, with the help of their "Dad" Glaxo is prepared to submit what should be a complete, all-encompassing response to the FDA on their "genetic mutation issue" within 10 days. When we got this last approvable letter, it was speculated by the street that it would take 6-12 months for POZN/GSK to do what they needed to submit a complete data set adressing the FDA's most recent bullshit.
Reading between the lines, I think there is very good reason that the stock was up 14% today on almost quadruple normal volume. Today's press release says one thing very clearly to me: The FDA and POZN/GSK have met since the 2nd approvable letter was issued and the FDA was clear to the two companies what they needed to feel comfortable. There is no way GSK would risk submitting anything this quickly if they thought for one second that it would not satisfy what the FDA wanted to see. GSK has WAY to much at risk to make a move that stupid with Immitrex coming off patent protection next year. Obviously POZN is taking the guidance of their partner with all of the experience and deep pockets, a good move in my opinion.
POZN will ask for an expedited review of the data and quick response on approval, which as I laid out as a possibility in the POZN Class Action thread some time ago, COULD mean approval on the new drug by Christmas, if not sooner.
I also agree with some investors that once POZN submits the new data, an announcement that the FDA is going to grant the expedited review will be a very good sign that will propel us even higher. Then the actual approval should get us into the mid $20's at least.
Also, remember that POZN has another great candidate in Phase III ( partnered with AstraZeneca) and one in Phase II due for a major partner any day now. This is not a one-trick pony and I would suggest that if the pre-FDA decision last time is any indication, you need to get in soon for what might be a run to $17 or so before a decision.
I believe in the story here and feel that positive news is forthcoming but as always biotech investing is risky so only play with what you can afford to see cut in half overnight.
To me this is a strong buy here and especially on any pullbacks. 
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