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Dynavax Technologies Corporation Message Board

imprvngmyavg 685 posts  |  Last Activity: Oct 9, 2015 1:26 PM Member since: Apr 5, 2012
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  • Reply to

    So this was pretty cool.

    by mpreorder Oct 9, 2015 1:16 PM
    imprvngmyavg imprvngmyavg Oct 9, 2015 1:26 PM Flag

    From where are you downloading your podcasts?

    Sentiment: Hold

  • imprvngmyavg imprvngmyavg Oct 7, 2015 5:03 PM Flag

    i thought it might help everyone understand what has been happening to the SP in the recent past and why standing pat until this clears itself up with more information down the road, which, is likely to happen at the SITC conference in MD on Nov 4th

    Sentiment: Hold

  • In the interest of providing some real information to those of us long on this equity and committed to the long term bet on its success. Hope it helps clear some of the confusion surrounding the clinical hold.

    This was published by"The Smarter Analyst" today at 1:04PM by Jason Cohen,Editor

    H.C. Wainwright’s healthcare analyst Swayampakula Ramakanth weighed in today with his views on Advaxis, Inc. (NASDAQ:ADXS), after the company announced that the FDA has placed a clinical hold on all four ongoing clinical studies of its experimental cancer drug after a patient died.
    Ramakanth wrote, “The clinical hold was issued in response to a safety report filed by the company involving one patient who had previously enrolled in an investigator-sponsored study in 2013. Prior to her death earlier this year, the patient had tested positive for Listeria monocytogenes (Lm) in her blood. According to both the lead investigator of the study and Advaxis’ investigation, the patient’s death was caused by respiratory failure due to metastatic disease and was not related to the Lm. However, we believe that the FDA has ordered the clinical hold as a precautionary measure due to the high mortality rate associated with Lm infections, and has requested additional information regarding this event.”
    “While we await the FDA’s recommendations for resolving the clinical hold, we believe that potential modifications to the studies may include: 1) excluding patients with prosthetic implants from enrolling in the studies; 2) increasing the course of antibiotics following each vaccine dose; and 3) conducting additional patient screens to ensure that Lm is no longer detectable. We do not anticipate these modifications to have any impact on the clinical outcomes of the studies,” the analyst added.
    Ramakanth reiterated a Buy rating on Advaxis shares, with a price target of $30, which implies an upside of 195% from current levels.
    According to, which measures analysts’ and bloggers’ success

    Sentiment: Hold

  • imprvngmyavg imprvngmyavg Oct 6, 2015 3:35 PM Flag

    The Confusion revolves around the term clinical hold which someone else posted The study is not on a clinical hold but continuing with existing participants, which is not a clinical hold as i see it, if someone continues to receive treatment, as best as I can tell, the FDA is not involved in the decision to stop recruitment. Though i have not been able to determine why recruitment has been stopped. I would think it would be incumbent on the company management to make sure issues such as these get clarified in a timely fashion but so far mums the word from management which, might explain the wild gyrations in the SP that are occurring on large volume. i don't know how you all feel about it, but I think DOC should be saying something, no news or ambiguity is poison to a biotechs SP.

  • imprvngmyavg imprvngmyavg Oct 6, 2015 3:14 PM Flag

    Here is the link as best as I can display it with spaces to get yahoo's message board software to allow it to post. take out the spaces and you have it

    clinicaltrials dot gov/ ct2/ show/ NCT01266460? term= GOG+0265&rank=1

  • imprvngmyavg imprvngmyavg Oct 6, 2015 3:11 PM Flag

    Here is the link as best as I can display it with spaces to get yahoo's message board software to allow it to post

    clinicaltrials dot gov/ ct2/ show/ NCT01266460? term= GOG+0265&rank= 1

  • Reply to

    GOG-0265 apparently on hold...

    by mcbridetina Oct 6, 2015 12:19 PM
    imprvngmyavg imprvngmyavg Oct 6, 2015 1:50 PM Flag

    This is what I found doing a google search of FDa Clinical holds not sure if it is relevant but posted FYI

    Under the Food and Drug Administration (FDA) regulations, an investigational new drug
    application (IND) is either allowed to proceed or placed on clinical hold (21 CFR 312.42). A
    clinical hold is an order issued by the FDA to the applicant to delay a proposed clinical
    investigation or to suspend an ongoing investigation. A clinical hold may be either a
    complete clinical hold or a partial clinical hold. An applicant may then respond to the clinical hold. Once
    the applicant has submitted a complete response to the clinical hold, the Agency must evaluate the response and decide whether to lift the hold.

    Section 117 of the Food and Drug Administration Modernization Act of 1997 (Modernization
    Act) provides that “Any written request to the Secretary from the applicant of an investigation
    that a clinical hold be removed shall receive a decision, in writing and specifying the reasons
    therefor [sic], within 30 days after receipt of such request.” In addition, in conjunction with the
    re authorization of the Prescription Drug User Fee Act of 1992 (PDUFA), the Agency committed
    to user fee performance goals incorporating the same response time. In her letter to Congress
    regarding re authorization of PDUFA, the Secretary of Health and Human Services committed the Agency to respond to an applicant’s complete response to a clinical hold within 30 calendar days of the Agency’s receipt of the applicant's complete response. Beginning in fiscal year (FY) 1998,the Agency has committed to respond to at least 75 percent of complete responses within 30 calendar days of receipt of the complete response. In FYs 1999-2002, the Agency will respond to at least 90 percent of the complete responses within 30 calendar days of receipt of the complete response.

    I am not sure what Mcbridetina is talking about. Maybe I should but I don't, based on the above. Did Advaxis submit an NDA?

    Sentiment: Hold

  • imprvngmyavg imprvngmyavg Oct 6, 2015 1:00 PM Flag

    "People with ED can use some hard on cream." LOL, Too funny

  • imprvngmyavg imprvngmyavg Oct 6, 2015 12:58 PM Flag

    I just don't see a big market for the kind of low nicotine cigarette this company has developed. I agree, The idea of healthy smoke is I Think somewhat Oxymoronic. Lowering the nicotine level just simply lowers the addictive quality of smoking, So what we're going to try and succeed in making it simply a bad habit.There are plenty of other carcinogenic substances in cigarette smoke. Lower nicotine smoke versus fresh air, which is healthier?now there's a trick question.

  • imprvngmyavg imprvngmyavg Oct 5, 2015 4:20 PM Flag

    22nd Century Group, Inc., a plant biotechnology company, focuses on tobacco harm reduction and smoking cessation products produced from modifying the nicotine content in tobacco plants through genetic engineering and plant breeding. It develops smoking cessation products and modified risk tobacco products for smokers who are unable or unwilling to quit smoking and who may be interested in cigarettes which reduce exposure to certain tobacco smoke toxins and/or pose a lower health risk than conventional cigarettes. The company’s products include RED SUN and MAGIC regular and menthol cigarettes; and SPECTRUM government research cigarettes. It is also developing X-22, a prescription smoking cessation aid, which is a tobacco-based botanical medical product for use as a smoking cessation therapy; and modified risk cigarettes, such as BRAND A, which has approximately 95% less nicotine than tobacco in cigarettes, as well as BRAND B cigarettes that contains low amount of tar per milligram of nicotine. The company was founded in 1998 and is based in Clarence, New York. Currently 89cents

  • imprvngmyavg imprvngmyavg Oct 4, 2015 3:07 PM Flag

    Did you ever spend some time in a bar called the Black rose near the Quincy market and across from the Aquarium. It was a great Irish bar.

  • imprvngmyavg imprvngmyavg Oct 4, 2015 2:45 PM Flag

    "the chinkey eyed delivery boy" Now seriously what did you think that added to your message. Its provacative and simply invites the conversation to go south. Chinaman I'm betting won't go for the bait. He obviously has a lot more clas than yourself. Sometimes I wonder what makes someone think the addition of gratuitous insults, will make their post be taken more seriously. Is that really something you would say to someones face if you didn't know them?

    Sentiment: Hold

  • imprvngmyavg imprvngmyavg Oct 4, 2015 2:28 PM Flag

    "We need leadership on this message board that focuses on ADXS investment talk and that does not encourage and engage in petty nonsense."
    Talk of leadership is all fine and good, however, It implies a willingness on those supposedly being led to follow. IF you think that simply ignoring our well known board plague and leading JACK AZ will allow a civil and intelligent conversation to ensue. His ego won't permit or acknowledge that he is viewed with great disdain. He will just continue to inject his vitriol and profane insults with impunity and it will get worse if everyone rolls over and plays dead. HIs demented mind would view it as acknowledgement that he is right. If the board decides on some leader. I am more than willing to follow his lead. Good luck with the attempt. i was by myself for the most part putting a pin in his BS bubble, when he gratuitously attacked, insulted and attempted to demean Tx.farmer. I am sure some cheered while others were saying; OMG, give it a rest already. When I attempted to get you guys to chime in with a guilty verdict. The Jury was unusually quiet. He is the kind that needs a universal and consistent message from all and a strategy of uniformly messaging the fact that he is pesonna non-grata from everyone not just two or three individuals who are willing to get in his face when he demeans and belittles other members of our community. Good luck getting someone to step up. AND I AM NOT RUNNING FOR THE POSITION. chinaman is a good choice I think because he is reasonable, rational, thoughtful and doesn't let it get personal and I think fairly well respected by all of us. JMHO

  • Reply to

    Absolutely amazed so many entertain CLG.?,!?,!?

    by tx.farmer Sep 27, 2015 10:55 PM
    imprvngmyavg imprvngmyavg Oct 3, 2015 2:28 PM Flag

    JACK AZ, tx. farmer contributes far more than you ever did on your best day or should I post another list of your past BS to drive home the point further. Everyone here has your number; YOUR JUST AN IGNORANT, VACUOUS, JACK AZ, FRAUD AND PRETENDER FULL OF PIZ AND VINEGAR, COPIOUS AMOUNTS OF BS AND NOT MUCH ELSE.

  • imprvngmyavg imprvngmyavg Oct 2, 2015 10:57 PM Flag

    "You have questions..... Macaluso has your answers" Wasn't he the guy you were saying lied to you when this tanked after a flubbed trial.Now he has all the answers. Your back to recycling old BS. Then again you never had anything original to say.

  • imprvngmyavg imprvngmyavg Oct 2, 2015 10:50 PM Flag

    The whole Biotech sector has been taking a beating. The only safe bet is if your invested in it is to get out. Your stock picks tend to get hammered loser.After what you have lost on AMPE and then on KERX, by now you don't even have coffee money and plunging Toilets for a living probably doesn't pay your opinion on anything is worth about as much as the shet you pull from plugged toilets

  • Reply to

    Hey JACK Az aka CLG, Wrong Again

    by imprvngmyavg Oct 2, 2015 9:10 PM
    imprvngmyavg imprvngmyavg Oct 2, 2015 9:24 PM Flag

    I agree, he will be scarce for quite awhile as this should stick a pretty big pin in his BS bubble and as deluded as he is, he and his assistant JACK Az demonstrably got their call wrong. Have a great day Batermere, Do you live anywhere near Denver?

    Sentiment: Hold

  • Reply to

    my bad timing

    by rdmlkes Oct 2, 2015 6:32 PM
    imprvngmyavg imprvngmyavg Oct 2, 2015 9:17 PM Flag

    He who laughs last truly laughs best.I am going to enjoy poking the Jack A in the virtual eye. He's not likely to show his face unless ADXS reverses again. Once it starts going up I don't think there will be any holding it back as people look closer at the GOG data and start realizing how good it was


  • Reply to

    Progress ???

    by sanchex456789 Oct 2, 2015 10:49 AM
    imprvngmyavg imprvngmyavg Oct 2, 2015 1:36 PM Flag

    "gift" To be sure!

    Sentiment: Hold

23.86+0.39(+1.66%)Oct 9 4:00 PMEDT