PDUFA is November 10. Given that the post marketing plan is a continuous interaction between the company and FDA and how the company said no later than 11/10 as opposed to by 11/10 or a simple PDUFA, the company was confident that it will get approved sooner. There is no reason for FDA to delay the approval because everything is set except for the post marketing study. As soon as they find the plan acceptable, approval should be granted sooner or rather later because lot more people die as result of the delay. If they have unanswered questions, they would be working with the company actively to meet the deadline. If not, they will approve. The FDA is proactive with post marketing studies because it's something within their control as oppose to trial data where they require lots of outside expertise.
Well ---- Manufacturing and a Sales Job ramping back up in Germany
What does THAT tell you
There are buyers out there if anyone wants to sell! I've had this stock for several years now (bought at $1.20), can wait a few more months.
That investor Village email is NOTHING NEW. Michael O said that same thing if you would have listened to the Investor Conference webcast or its playback from 2 weeks ago
stagnant day... I have a theory
be patient J, it's coming
DVAX IS INVESTORS BEST CHANCE FOR HUGE GAINS
Thought you "Old Timers" would enjoy a sarcastic Blast from the past
A#1 STILL has NO clue or he's very very good at lying
4 Trading Days til CantBeAHoe investor conference. Wonder if its Six and a quarter Cent Eddie or Michael presenting???
Looks like DVAX is not scheduled to attend the 2017 Liver Meeting happening this week. In 2016, DVAX scheduled itself to attend and had a booth reserved but canceled around the time they received the CRL for Heplisav-B. I believe the company's decision to not attend the meeting this year should be interpreted indifferently or slightly positive. Their scheduled attendance in 2016 was prior to PDUFA and could have been viewed as presumptuous by the FDA. Remaining humble is the best course of action. https://www.aasld.org/events-professional-development/liver-meeting/exhibits-advertising/exhibitor-listing
2017 Exhibitor Listing | AASLD
Well Kieth if VP Spencer confirmed to you NON PUBLIC info then I'd say this guy - who has only been in the job since Feb 2017 is about to lose his job AND YOU should be very cautious trading on privilege Insider Info at this moment
Another DVAX type move potential? ACRX starting to make a move (2 back-to-back NY presentations next week). ACRX's Dsuvia FDA approval decision is on October 12th. European EMA accepted the Dsuvia application and is now under review for approval. ACRX's Zalvsio NDA application is expected to be filed in October too. Zalviso is approved in Europe, and ACRX has received $100 million dollars in milestone payments from Europe Zalviso, thus ACRX has ONLY 45 million shares outstanding!
I wouldn't call 9 cent getting hammered....
not what I was expecting. hope this isn't one of those situations when the good news is already priced in and when they release the PDUFA official news release it tanks big time
As a long term investor, I care little about day to day trading. I'm in DVAX for the long haul. I expect big things from DVAX, though sooner than later, at this time. Institutional holding in DVAX are just slightly more than 60%, as low as they have been for DVAX for quite a while. Seeing where that percentage goes after this quarter, will tell a lot about where the "Big" stock players think DVAX is going. And, at that point, they'll have a month or so to add to their position before approval of HepB vaccine. If the institution holdings percentage goes up with this quarters reporting, then that will trigger a real jump in DVAX price. That's what I think is going to happen.
This makes sense. They must have submitted the post marketing plan a while back. Like how the user quoted Spencer. The interaction is continuous until the FDA doesn't come back with big concerns of the overall design. And if they do, they certain would raise the concern long ago to make sure DVAX has time to address it. I would say no news is good news from now on. Previously I was expecting some news but not anymore. Spencer's email really makes sense.