POZN.......train leaving the station in the next few weeks?

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.

 

 

Just watching this one.....I'll be wrong if I go long, and wrong if I go short.

 

POZN would do exactly what I wouldn't want it to do.....LOCK.

 

But, hope you get far in the clear, ACC.

I have spoken to two folks at GSK that are friends of my partner and they have given me some added assurance in the last month or so.  GSK is working very hard on this one and I think it gets done.

I would also not rule out a buyout by either GSK or some other big pharma.  The CEO of POZN needs to go and he can only screw up three very promising drugs so I have a gut feeling they get him out of there and a buyout would be a good way to approach this.  See their 8-K last week.  Interesting.

POZN weak today.  Any news?

Could be an interesting day for POZN.  Is anyone expecting any major news from their webcast at 11:00?

 

 

downgrade today.

 

I listened to the CC yesterday.  They appear confident that the FDA will accept their response on the cell toxicity issue without the study.  They are however doing this extar study no so that in case the FDA does request it down the road, they will already have it under way and will not have to start from scrathc.

 

I expect the FDA will tell them yeah or nay on the 60 day expedited review request by the middle of next month. 

 

This one is going to be very interesting.