Dynavax Technologies Corporation Message Board

dnb2020 33 posts  |  Last Activity: May 9, 2013 3:44 PM Member since: Apr 16, 1999
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  • Vette, CTIC, Raven, Stevens and newer additons like Outboard....I don't recall seeing much from Dashaft lately......however, with so many oldtimers posting here is it safe to assume that there is a renewed interest in DVAX price appreciation opportunities? Really surprised to see such low volume today since I had to go back quite a ways to see any volumes under 1 million shares....

    Sentiment: Hold

  • dnb2020 dnb2020 May 9, 2013 1:43 PM Flag

    Just to close the conspiracy loop wasn't it GSK that jumped ship very early on when DVAX had problems and the trials were halted....then they wanted back in and DVAX said no...so GSK got Daum to slam the FDA door, got Dino/Martin fired and put Grey into place.....since GSK has so much influence on EU and FDA and the decision to approve or deny Heplisav is still pending in Europe I hope Grey calls Daum to get him to reverse course and get EU approval right now and get DVAX to market sooner....GSK wins, Grey wins and DVAX shareholders win

    Sentiment: Hold

  • I think we can all guess right now that a large scale study is going to be required...meanwhile DVAX is diluting the PPS with its offering announced last month to raise funds to finance that trial which I think will take 6 months to complete and then another 6 months to get before VRBPAC again.....and yes I do think DVAX files in June for CKD use and gets partial approval before yearend.......finally EU likely does not approve at this time either.............what does the new larger trial do to the PPS since it has not been formally announced even though it is widely expected? My view is that the stock drops to $1.80 again for a couple of weeks and then works its way back to $5 by the Spring of 2014.....am I too negative or optomistic here?

    Sentiment: Hold

  • dnb2020 dnb2020 Apr 19, 2013 2:03 PM Flag

    so what is new....that is already known and why the stock tanked in the spring......what you don't say is that there were other outcomes like getting the CKD filed and approved quickly etc......at $2pps you guys are full of it to think the company will implode when 100% efficacy is already proved and accepted by the FDA

    Sentiment: Buy

  • dnb2020 dnb2020 Apr 18, 2013 5:04 PM Flag

    soup, I don't hold any grudge against you or shorts...that is what makes a market....I do however, disagree with your conclusion and here is why.....the request to increase shares to protect hostile takeover is a farce...I guess they think we are stupid.....you can have a poison pill and stop all hostile takeovers....the shares are likely to be used to raise funds like they are currently doing and many companies have 300-500M shares outstanding but not issued for future use....I see this as a long term unknown or maybe as I predicted that GSK would take a 20% interest in DVAX just like they did with THRX....as for mismanagement there is no doubt that exists here...but the efficacy is 100% certain and that is the real prize...I would be worried too if I were them and the stock price/market cap was this low without protection from a hostile bid...I wouldnt be surprised if they have already received offers

    Sentiment: Buy

  • Reply to

    Close HOD

    by outboard.jack Apr 18, 2013 4:02 PM
    dnb2020 dnb2020 Apr 18, 2013 4:06 PM Flag

    it's about time..... 2 buck pps is a joke

    Sentiment: Buy

  • dnb2020 dnb2020 Apr 18, 2013 1:52 PM Flag

    why wait for the analysts to provide an upgrade? they are always late to the game anyway....it is better to provide guidance before it happens so the retail shareholder can profit too.....my upgrade to buy pps is $7.50....imho

    Sentiment: Buy

  • dnb2020 dnb2020 Apr 18, 2013 1:30 PM Flag

    I think the delay in DVAX announcing the FDA meeting is because they are working thorugh a very detailed complex solution that works....not holding back bad news and worrying about the stock price....for example didn't the advisory committee notes say that they would have approved DVAX for limited use but they applied for the widespread use?.....why does DVAX need to reapply then? Just provide the other studies to FDA and bring in the advisory committee vote count for that use......the only drawback to this argument is that FDA is a government agency and inherently beaurucratic.....but they are less so than other govt agencies....I am upgrading DVAX to a buy since I think they get some limited approval now without further studies and reapplying....they pull a rabbit out of the hat on everyone...imho

    Sentiment: Buy

  • John Jenkins, M.D., director of CDER's Office of New Drugs, says, "It's often a combination of problems that prevent approval." Close communication with the FDA early on in a drug's development reduces the chance that an application will have to go through more than one cycle of review, he says. "But it's no guarantee."

    The FDA outlines the justification for its decision in a complete response letter to the drug sponsor and CDER gives the sponsor a chance to meet with agency officials to discuss the deficiencies. At that point, the sponsor can ask for a hearing, correct any deficiencies and submit new information, or withdraw the application

    Sentiment: Hold

  • What's up people? Here is a summary as to how I see it
    1. DVAX announces FDA path to approval. The message is mixed. Short term CKD and longer term large study to roll out in allpopulations in the U.S.
    2. DVAX raises $50M with some minor dilution (completed)
    3. DVAX files CKD application. Receives meeting date in October 2013
    4. DVAX closes out manufacturing queries with FDA from the CRL
    5. GSK takes a 20% minority ownership in DVAX and a seat on DVAX's board
    6. DVAX receives only limited use for CKD in Europe
    7. DVAX safety study on large scale population is announced and completed by Feb 2014
    8. DVAX receives FDA date for all populations June 2014
    9. DVAX gains panel approval Sept 2014
    10. GSK makes unsolicited bid for the remaining shares of DVAX Nov 2014 @ $15/pps

    That's my timeline and forecast.....I will look back and see how close my predictions were.....regardless @ $2 pps this is too low a price for the potential knowing that the efficacy has already been demonstrated...

    Sentiment: Hold

  • Reply to

    I wish the news release would just happen already

    by dnb2020 Apr 12, 2013 12:05 PM
    dnb2020 dnb2020 Apr 16, 2013 11:38 AM Flag

    soup...I agree 100% that Daum sabotaged DVAX's chances and we should have already been rolling along and flying high....no doubt he took an extremely harsh view and influenced his less qualified colleagues at the meeting.....but remember he only slowed us down and cannot stop it...he knows it, Dino knows it, the analysts know it and you probably know it too...either the vaccine is safe according to FDA guidelines or it isn't .....there isn't any middle ground unless you consider limited use as a failure too.....still believing that DVAX $12-20 pps in the next 12-18 months

    Sentiment: Hold

  • Reply to

    I wish the news release would just happen already

    by dnb2020 Apr 12, 2013 12:05 PM
    dnb2020 dnb2020 Apr 16, 2013 8:45 AM Flag

    i do find it very interesting that the same people like you and neut that cheered this underdog on for years now thinks they suck....the Hep B market including newly added diabetes is over $1B in revenue alone....DVAX market cap should be a multiple of that....say 3-5X so you can get them to be a high price stock on Heplisav alone......forget about the rest of the pipeline.....then you add a panel vote for almost 100% efficacy and a requirement for a longer term safety study before a major rollout is permitted and that recipe is this stock will fly at some point.......you two are both a doubting thomas......whatever works for you but I will keep smoking and drinking whateever you think I am misinfiormed about....

    Sentiment: Hold

  • Reply to

    R&R

    by soupsandwichcombo Apr 15, 2013 11:42 AM
    dnb2020 dnb2020 Apr 15, 2013 12:03 PM Flag

    We will have our day too! I just sold my THRX for a 3 day 20%+ gain and rolled it back into DVAX....the price should rise over time...we are at the bottom....stock has moved from 1.80 to 2.30s with no news whatsoever from FDA....only the $50M capital raise for the next study....

    Sentiment: Hold

  • Reply to

    Dynavax

    by suzycat717 Apr 13, 2013 7:50 PM
    dnb2020 dnb2020 Apr 14, 2013 8:11 AM Flag

    that's why they are selling stock for an extra $50M....they have telegraphed to the market that they will do the mega study and the cash will be in hand when they announce it....solid fundamentals and if I can read between the lines the study will only be needed for a three to six month period on a 30-50K population to satisfy the wacky professor's convcerns about the unknown safety risk...all imho

    Sentiment: Hold

  • Reply to

    Dynavax

    by suzycat717 Apr 13, 2013 7:50 PM
    dnb2020 dnb2020 Apr 14, 2013 8:07 AM Flag

    i agree with you suzy....my only saving grace is that the stock has been beaten down hard and there is very little expectations from them now....any delays will be a yawn sinc we have seen that show for years now....but any good news will light this candle....and with so much promising upside with an almost perfect efficacy rate I am willing to wait longer for the title fight and ring....and if they are any good at all they will take some smaller short terms wins now, do the mega study and grab the ring for the entire Hep B market in the next 18 months

    Sentiment: Hold

  • Reply to

    I wish the news release would just happen already

    by dnb2020 Apr 12, 2013 12:05 PM
    dnb2020 dnb2020 Apr 12, 2013 4:52 PM Flag

    hey neut.....I know we all have been burned by the FDA advisory committee but I still strongly believe in the product...just annoyed by the smaoke and mirror of the delays.....unless you believe that guy who led the panel that significant adverse reactions can occur then it just becomes a waiting game and lots of money to pay for a new trial.....one year delay for full approval but it rewards DVAX with $2-3B in annual revenuers is a good enough trade off for me

    Sentiment: Hold

  • we all know it is going to be good.....it is just a matter of whether it is partial approval now or a study and full approval later....timing......so lets light this candle and see some positive momentum.....the shares sold after the news should fill the bank accounts....that is what I believe will happen to a large extent

    Sentiment: Hold

  • Reply to

    What am I missing?

    by yellotulip1 Apr 1, 2013 8:18 AM
    dnb2020 dnb2020 Apr 1, 2013 2:57 PM Flag

    the sale was not completed for a discount....it will be a slow steady and almost unnoticeable distribution of shares at market.....as long as they don't panic sell we will be fine....their war chest will be pretty big at around $175M in the next couple of weeks.....and outboard is right that this could be seen as a lining up for selling based on goof FDA news and less shares required to get to $50M target......this stock is due for a major good news curveball right now to catch the shorts off balance!

    Sentiment: Hold

  • Reply to

    DVAX---Shelf Offering !

    by vette1967jc Mar 30, 2013 10:26 AM
    dnb2020 dnb2020 Mar 31, 2013 4:27 PM Flag

    I don't like this at all. I don't know if this means new shares which is dilutive since the majority of outstanding shares is owned by institutions. If you are raising $50M that is a clear announcement that a lrge trial is needed...that is based on the slide deck that DVAX issued last month where they showed investors the low cost to commercialize Heplisav......if Dino knows ths from FDA already due to this announcement and then in a week or so says new P4 is required I would equate that to mean he knew all along and qualifies as a dumbazz in my rating system imho of course

    Sentiment: Hold

  • at least this is very salvageable.....even I have to remind myself that the vaccine is effective and in fact much more effective than Big Pharma....2013 will be a year of stealth since we will see some nice PRs about FDA path forward to CKD and perhaps another limited use in 2013.....Phase IV study to commence for wide use in 2014....EU approval limited use in summer 2013.....maybe even a news release that we have received a hostile bid....lots of upside which could bring us to $10.....I was hoping without the safety snafu for $20+ so this is a disappointment but at $2 has some decent upside here....downside is back to $1.50ish with longer delays past 2013 for any approval anywhere or that leader of ours tries to dilute the shareholder...hopefully he won't try any of that nonsense after he torutred the shareholders already.....and lets not forget that we can potentially still partner with GSK and get Daum as part of our team to gain approval....its a money game and if GSK gets a nice slice they will push hard for FDA approval right now for the whole shooting match and Daum will deliver it with a great big bow on it jsut like Clarke's cousin-in-law Eddy did!

    Sentiment: Hold

DVAX
2.48-0.03(-1.20%)May 20 4:00 PMEDT