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Skullcandy, Inc. (SKUL) Message Board

meifud 560 posts  |  Last Activity: 13 hours ago Member since: Dec 1, 2008
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  • We believe that at least three key aspects of the DCVax technology contribute to the positive results (described more fully below) seen in clinical trials to date:

    (1) DCVax is personalized, and targets the particular biomarkers expressed on that patient’s tumor. Extensive scientific evidence has shown that there is substantial variation in tumor profiles and characteristics among patients with the “same” cancer. The degree of variation is particularly large in some of the most aggressive cancers, such as GBM brain cancer and pancreatic cancer. Cancer drugs are typically keyed to a single target which is believed to be found on the cancer cells’ surface or in one of the cancer cells’ signaling pathways in a substantial percentage of patients with a given type of cancer. Such drugs are of no use in patients whose cancers do not happen to express that particular target, or cease expressing that target as the disease progresses. Most cancer drugs only achieve clinical benefits in a limited percentage of the patients with the type of cancer being targeted (e.g., 25 - 30% of the patients). In contrast, DCVax has achieved clinical benefits (i.e., longer delay in disease progression and longer extension of survival than with standard of care treatment) in over 80% of the patients who have received DCVax in clinical trials to date. Since DCVax is made with biomarkers from the patient’s own tumor, it is automatically tailored to targets that are present on that patient’s cancer.

    message board readers -- parts 2 and 3 to follow...

  • Reply to

    forget the pumping, stick with the facts

    by rfwelsh Apr 2, 2015 11:27 AM
    meifud meifud Apr 2, 2015 12:03 PM Flag

    you sure are sounding a lot like you did last June when you were stating with great certainty how all sorts of things were going to happen exactly when, and that the price would explode with each announcement of a study starting or a study finishing or a plethora of generics being approved -- and you were telling everyone to buy in the .40's back then

    of course, your projected schedule fell apart almost as quickly as a march madness bracket and you spent many months taking pot shots at your former hero, Hakim, but here you are again all excited with spittle flying everywhere after selling at a loss and now wanting everyone to follow your lead so you can what? oh, that's right, you're looking for a quick percentage pop so you can make even a quicker exit, just like last year

    fwelch, don't know where you get some of your numbers but perhaps you ought to realize that they are all over the board with respect to sales and pulled out of thin air with respect to percentages, and that you need to settle down, take many deep breaths, and decide on one set of numbers and also decide why you are here

    when you have done that, hopefully, you will:
    -- stop talking about generics
    -- accept that none of the interim steps toward approval have yet moved ELTP
    -- and, either be in for the long haul and stop posting every day or admit to being a ADH day trader

  • from Forbes interview with analyst who has beaten the #1 best mutual fund for the last 10 years, and who says Northwest is his #1 best pick...

    "Branko: The market valuation of NWBO is around 420M, up to 5 times smaller than other small biotechs that have excited Wall Street. KITE, JUNO, BLUE are examples of companies enjoying much higher valuations, they have CAR-T cell treatments under development (single agent antigen treatments). NWBO should be valued at least at these same levels, especially considering their vaccines have a seemingly superior mechanism of action (attacking ALL cancer antigens instead of just one) and their vaccine is also showing an excellent and superior safety profile.
    NWBO’s vaccines are also much further along in their clinical development. DCVax-L at Phase 3 and DCVax-Direct will soon move to Phase 2 in the clinic. JUNO and KITE treatments are just entering the clinical stages."

  • Largest Institutional Ownership of NWBO
    ...........Name..........................Shares Held...% of Outstanding....Change.....Date
    Woodford Investment LLP........7,279,543..........11.70% ...........+936,922...01/30/15
    BlackRock Fund Advisors.........1,570,555...........2.52%............+358,456...12/31/14
    The Vanguard Group................1,219,320..........1.96%..............+96,886...12/31/14
    Goldman Sachs........................1,076,166..........1.73%.............+229,037...12/31/14

  • perhaps 'costs' could more accurately be spelled m-a-r-g-i-n c-a-l-l-s

    what else to explain the big sells that keep appearing at that price but so far today have just been sham orders that quickly get pulled down -- because shorts really do not want to open any more positions now that Woodford has made his intent known

  • none of the trials have been stopped so we must be getting closer to data
    there are no longer any financing issues for this year which gets us through the trials
    German reimbursement negotiations have entered the usual window for resolution
    revenues from patients already being treated will be reported for the first time
    the information arm has provided promising results
    institutions have become aggressive buyers
    Woodford, Woodford, Woodford...

  • meifud meifud Apr 19, 2015 7:19 PM Flag

    pretty much the same as Buffett, Buffett, Buffett, but with a British accent and better morals

  • DCVax Product Lines

    We have developed several different product lines based on the DCVax technology, to address multiple different cancers and different patient situations. There are two main components to each DCVax product: the immune cells (dendritic cells) and the cancer biomarker targets (antigens).

    All of our DCVax product lines are made from the patient’s own dendritic cells. The dendritic cells are freshly isolated, and newly matured and activated. We believe that the existing dendritic cells in a cancer patient have already been compromised by the cancer, and we believe that is the reason other vaccines aimed at the existing dendritic cells in patients have largely failed. However, the patient’s body continues to produce new precursors of dendritic cells, and these precursors (monocytes) circulate in the patient’s blood stream. For all DCVax products, these precursors are obtained through a blood draw, and then (through our proprietary manufacturing processes), the precursors are matured into a fresh, uncompromised batch of new dendritic cells.

    The antigen (biomarker target) component, which is combined with the fresh, personalized dendritic cells, varies among the DCVax product lines.

    Importantly, each of our product lines has an excellent safety profile. Patients may develop some flu-like symptoms, but there have been no toxicities such as are seen with chemotherapies and with some other types of immune therapies. Patients do not have to take a second set of drugs to manage side effects, there are no in-patient hospital stays to deal with side effects, and patients do not have to go home and stay in bed for several days to deal with side effects. Our DCVax patients typically go on with their work and their daily activities.

    message board readers -- descriptions of each of Northwest's DCVax products to follow...

  • Reply to

    In case any of you are wondering

    by rationalthought11 Apr 15, 2015 3:10 PM
    meifud meifud Apr 15, 2015 3:53 PM Flag

    market cap is always based on outstanding shares, not fully diluted
    fully diluted may never happen but, if and as it does, the rules of supply and demand should be expected to adjust the price accordingly

    of course, what we have been witnessing is the price going higher along with the increase in shares which shows that the market is really getting behind Northwest and driving its market cap higher

    seems to be that everything is going in Northwest's favor, and it is making each financing easier and more lucrative -- something that you didn't seem to foresee in the post below...

    "You need to consider
    by rationalthought11 • Aug 26, 2014 2:47 PM
    but probably haven't, that the notes introduce another layer of risk to NWBO. A very serious risk. The notes are due in 3 years. That would be 17.5mm. As notes they are senior to all your equity. If NWBO cannot repay the notes, the holders can take the entire company in 3 years (plus the time it taKes in bankruptcy) Of course NWBO csannot repay the notes unless they raise additional capital from somewhere els. The notes establish that the terms pun which NWBI us able to raise capital are gettign more dear with each round. Yet another reason to stay on the sidelines of enow"

  • meifud meifud Mar 18, 2015 11:39 AM Flag

    DCVax-L - is designed for operable solid tumors. It is made with cancer antigens from tumor lysate (a protein extract from processed tumor cells) from the patient’s own tumor tissue. As such, DCVax-L incorporates the full set of tumor antigens, making it difficult for tumors to find ways around it (“escape variants”), as described above. This is the DCVax product that has been used in our brain cancer and ovarian cancer clinical trials, and is currently in our 348-patient Phase III brain cancer trial. DCVax-L is expected to be applicable for any type of solid tumor cancers in situations in which the patient has their tumor surgically removed as part of standard of care.

    DCVax-Direct - is designed for inoperable solid tumors – situations in which it is not feasible or not desirable for patients to have their tumors surgically removed, either due to multiple metastases or for other reasons. Like DCVax-L, DCVax-Direct also incorporates the full set of tumor antigens - but it does so in situ in the patient’s body rather than at the manufacturing facility. With DCVax Direct, the fresh, new dendritic cells are partially matured in a special proprietary way so as to be ready to pick up antigens directly from tumor tissue in the patient’s body, and also communicate the information about those antigens to other agents of the immune system, such as T cells. The partially matured dendritic cells are then injected directly into the patient’s tumor(s). There, the dendritic cells pick up the antigens in situ rather than picking up the antigens from lysate in a lab dish at the manufacturing facility, as is done with DCVax-L. DCVax-Direct is anticipated to be applicable to any type of inoperable solid tumors.

    message board readers -- the above are Northwest's most advanced products in terms of FDA trials, a description of DCVax-Prostate will follow...

  • seems that would get Northwest past the interim analysis for Phase III for L vaccine and/or the final analysis for Phase II of Direct -- either one of which should jack the stock to where is should be easy raising money to finish the trials, get everything submitted to the FDA, and start building manufacturing plants

  • Reply to

    forget the pumping, stick with the facts

    by rfwelsh Apr 2, 2015 11:27 AM
    meifud meifud Apr 2, 2015 3:52 PM Flag

    woa, woa, woa there now, you were amongst those criticizing me for selling all shares in my Roth during that run (average in the .70's) to buy NWBO

    yes, i did hold my regular shares and have no regrets because they were bought in June of 2013 at less than .08 per share and i was not interested in paying short term capital gains when the plan has always been to hold them very long term and sell slowly to keep taxes down -- no such concern with the Roth

    so, as to your characterizing yourself as a smart investor because you took a small loss, let me suggest to you that most of the folks you are talking to on this board have lost nothing, nothing at all
    for you to claim they 'lost' by not selling at .97 is just a bunch of woulda/coulda/shoulda that applied to you means YOU LOST BIG TIME by never buying in the single digits and then selling at .97

    let me suggest that you stop losing money, and truly become a smart investor by buying ELTP and holding it until some of the adults on this board suggest otherwise. in the meantime, give you posting a rest and give us all a break

  • meifud meifud Mar 8, 2015 6:16 PM Flag

    actually, pbyi had reached a nine billion market cap before issuing more shares and the stock falling from its high, and they had not even begun phase III trials

    in the near term, NWBO is already ahead of pbyi in terms of trials and obtaining FDA approval which is why i'm suggesting a new $1.2 billion cap on simple news, and a $5-9 billion range for NWBO on anything hard/definitive

    in the long term, NWBO will be be multiples higher than pbyi because it is going to transform cancer treatment across a broad front

    the potential for this stock is just enormous, and that is even before they begin improving on the vaccines currently going through trials

  • balance sheet looking better than ever -- literally
    and it sounds like one of the shortest and cheapest phase III trials ever
    ELI-200 should be on its way to the FDA with minimal dilution involved

  • the first approval can do it because it will confirm the technology and open the floodgates for everything in the opioid pipeline while quickly expanding the portfolio to other drugs

    there is not going to be a need for a reverse split, and the days of dilution are rapidly coming to an end

  • meifud meifud Feb 27, 2015 10:54 AM Flag

    Woodford must really like what he is seeing and hearing from the medical community in England now that they have their own trials underway -- NOT suggesting he is seeing any blinded data, just that optimism has a way of showing itself

  • meifud meifud Mar 18, 2015 11:29 AM Flag

    (2) DCVax is designed to target not just one but the full set of biomarkers on the patient’s tumor. As mentioned above, cancer drugs are typically rifle shots aimed at just one target on a patient’s cancer. However, cancer is a complex and variable disease. Tumor profiles vary among patients with the “same” cancer and also vary as the disease progresses. Further, when rifle shot drugs hit individual targets on cancers, the cancers find ways around them (called “escape variants”) - and the rifle shot treatments then usually stop working. DCVax takes the opposite approach: instead of aiming at a single target, DCVax is aimed at the full set of biomarkers on a patient’s cancer. Such treatment approach is expected to make it more difficult for tumors to develop escape variants.

    message board readers -- part 3 to follow...

  • so how many of you are feeling it

    we get some results/observations/disclosures for Direct like last year, and NWBO's market cap is quickly hitting $1.2 billion

    if it's something that sounds plausibly definitive, that cap is going to explode and trade in the $5-9 billion range just waiting o FDA approval

  • meifud meifud Mar 18, 2015 11:30 AM Flag

    (3) DCVax is designed to mobilize the overall immune system, not just one among the many different categories of immune agents in that overall system. As described above, DCVax is comprised of activated, educated dendritic cells, and dendritic cells are the master cells of the immune system; they mobilize the rest of the immune system. Some of the prominent cancer drugs today are composed of just one type of antibody - and antibodies themselves are just one type of agent in the overall immune system (see Diagram 1 above). In contrast, the full immune system involves many types of antibodies, and also many other kinds of agents besides antibodies. There have been a variety of early immune therapies that failed in the past. These typically involved single agents, such as a single one among the many types of immune signaling molecules (e.g., a particular interferon or interleukin), or a single type of agent such as T cells alone, etc. In contrast, dendritic cells can mobilize all of these different categories of agents, comprising the overall immune system, in combination with each other and in their natural relationships to each other.

  • Reply to

    forget the pumping, stick with the facts

    by rfwelsh Apr 2, 2015 11:27 AM
    meifud meifud Apr 2, 2015 6:12 PM Flag

    when i continued saying good things about Hakim after the drop in July, you joined others claiming i was back to pumping after having dumped -- but you all conveniently ignored that i had only sold in the Roth

    you actually need to think less because you are leading yourself into whole scenarios to explain the price movements and volume in ELTP and what is going to happen at various price points and, and, and, really it is fit for fiction

    your posts suggest you see this more as a video game than investments being made by real people making buying and selling decisions -- and they don't nearly conform to your narrow and naive psychological interpretation of what is going on

SKUL
11.13-0.0300(-0.27%)Apr 24 4:00 PMEDT