PA is a SAFER aspirin. The safest and oldest and most used drug in the world. So in fact it would be easy to turn this drug into a blockbuster drug...HZNP has the money to buy a 50% stake . Watch and see....HZNP will get the USA rights for PA on a 50/50 base. Means HZNP will take all the costs for selling the drug in the USa and POZN will receive 50%. You know why HZNP will buy the PA rights? Because there is simply not 1 other drug in the market with this kind of opportunity.... not at these prices!!!! BAYER can not keep bribing the FDA for ever to keep PA out of the markets.
ohhh and 1 more thing... with all the assets POZN has, this stock would be never under $15 with a "normal" CEO. Not even a bright one. Sorry Dr. PLACHETKA, maybe you WERE a good doctor and maybe you ARE a good doctor, but as a CEO , you are a BIG ZERO!!!!
Make sure that the volume is relative high and the increase in pps is steady... so the FDA guys and family are starting to buy.....because they are the first to know what news is coming....
And do not tell me it is illegal !!!
Plachetka maybe is the biggest loser as a CEO of a bio tech company. He never did anything to put his compnay on the radar of big funds/investors. He rarely go to meetings, MC Namara the same... I wonder what they are doing all year long beside writing an email or do some phones.... come on... even the CFO.... why he should get a full time payed job? POZN's bookkeeping is very simple now.... even a 18 year old student could do POZN's bookkeepings in about 1 or 2 hours/week work.... so the $3million/quarter cash burning because they have to do some prparations for launching Yosprala... I would like to see their costs for that preparation in detail. Because in my oiopnion.... a lot of that burning money disappears in the pockets of some POZN managers inderectly.... so in fact, they are pleased that Yosprala is still not approved.... every year is a year they can act like the have to burn some cash. This company could be run with less then $1million/year !!!!
1 or more funds are buying. YOu will see, when they finished buying, you will see a sec filing who bought and how many shares they bought. I wouldnot be surprised to see PAR invest adding more. They bought a lot POZN shares around $7 / $7.5 in the past. And for a fund.... 6 months is nothing and many people seems to forget that Yosprale is in fact already approved, the FDA said TWICE to POZN that there are not other issues then the supplier. How many drugs are in the same situation and are valued near to nothing? ANd in the right hands, Yosprala will become close to a blockbuster drug. No doubts about that. So in fact we have an already approved semi blockbuster drug that has to wait a few months more (12 months) to get on the market..... at this moment,; POZN should have at least 50% of the market cap of HZNP. Bbut alas, because there are only 32 million shares available... big funds will never touch it... because in case of emergency (quick selling) , it is impossible to sell. Good luck and see you in 2020.....
Exactly.... the supplier did not want to make the probably huge investments only because POZN could become a good customer.... but now that the FDA has send a warning letter to the plant.....if they do not fix the issues, they will lose all their USA customers.... so they are now forced to solve the issue.
1 question no one asked... let say that today, the compliance said.... the plant is ok now..... that doesn't mean that tomorrow PA is approved. I think POZN has to file a NEW NDAand can ask for a 2 month review... so that alone will take minimum 3 months. So in best case, when the plant is ok within 3 months... the procedure to get approval is also min. 3 months 6 months.... and that is in fact the reason that POZN said the release will be in 2016 and now we can only prepare for that release and try to find more interested parties for partnering.... . ALso, nobody asked Plachetka.... how about the partnering for the other drugs... M400, Treximet for ROW etc.... POZN let the time destroy those assets because of expiring patents
Make sure that POZN managers aready know at around what time the approval of PA will come in and with whom they will dealing with and at what %%%%. Or a buy out and already discussed the PPS with those buyers.... or a partly buy out ...... as mentioned by some other board members. And in the mean time, POZN will receive around $20m / year from all other drugs..... seems a safe investment to me at this moment.....but PLachetka should GO and take place for a REAL businessman on the wheel of POZN!!!!
And on such a news... the PPS will sky rocking..... because PHASE 1, 2 and 3 trials can only be financed by partners. So when they find a big bio as a partner... they will receive up front payments and %%%% on later sales...... Ebola will not be gone in the near future...... and when it works with Ebola.... it will work with other virusses as well......
ok, i understand.... 483 issues would be rediculous anyway...... I stil have the strong impression that the FDA is boycotting POZN since IPO. It can not be a coincidence anymore... the FDA always was against approval of Treximet, Vimovo and now PA..... unbelievable that such can happen. And now the PPS is a $6... maybe now they will approve.... so the FDA was very successful in their efforts to boycot Plachetka....
At the meeting, representatives from the Office of Compliance stated that the active ingredient supplier’s responses to the 483 inspectional observations submitted in May 2014
Read this : FDA granted the Type A meeting, which was held in late January 2015 and included representatives from POZEN and its active ingredient supplier, the FDA’s Office of Compliance and the reviewing division. At the meeting, representatives from the Office of Compliance stated that the active ingredient supplier’s responses to the 483 inspectional observations submitted in May 2014 were still under review and the Office of Compliance would be communicating with the supplier in the coming weeks.
POZEN has provided and will continue to provide assistance to its active ingredient supplier in taking corrective actions to address the inspectional observations at its facility.
So the FDA in fact stated at that meeting , just 2 weeks ago, that they did not have had enough time to review all information that the active ingredient supplier gave them. This means that any given day... an APPROVAL can come in.
All we can do is wait and see and read the SEC filings !!!!