Seeking Alpha

Smith On Stocks

 
View as an RSS Feed
View Smith On Stocks' Comments BY TICKER:
Latest  |  Highest rated
  • Refuting The Latest Negative Blog On Northwest Biotherapeutics [View article]
    It didn't hit the PFS endpoint.
    Apr 4 11:35 AM | Likes Like |Link to Comment
  • Refuting The Latest Negative Blog On Northwest Biotherapeutics [View article]
    The FDA looks at the totality of the evidence. It all depends on the data. As I stated in the article PFS correlates with OS so I am not sure that you could have a dramatic effect in one and not the other.
    Apr 4 11:34 AM | 1 Like Like |Link to Comment
  • Refuting The Latest Negative Blog On Northwest Biotherapeutics [View article]
    The FDA does not allow companies to retrospectively change the primary endpoint of a trial. However, there was one exception and that was when Dendreon changed its primary endpoint for Provenge from progression free survival to overall survival.
    Apr 4 09:01 AM | 3 Likes Like |Link to Comment
  • Refuting The Latest Negative Blog On Northwest Biotherapeutics [View article]
    You are one of the few people on this message board who understands this. It is this point that P-man is missing in his analysis. It is why delaying the progression of the tumor in GBM is so important.
    Apr 4 04:39 AM | 9 Likes Like |Link to Comment
  • Refuting The Latest Negative Blog On Northwest Biotherapeutics [View article]
    If you did some work to understand the hospital exemption early access program, you would understand. From your comments, it is clear that you don't.
    Apr 4 04:24 AM | 3 Likes Like |Link to Comment
  • Refuting The Latest Negative Blog On Northwest Biotherapeutics [View article]
    Could you explain to me what you believe the German hospital exemption early access program is and don't say that it is named patient compassionate use, because it is certainly not. After we have come to an agreement on what this program is, could you explain the following regulatory action?


    The Paul Ehrlich Institute (the German equivalent of the FDA) has approved DCVax-L for all gliomas, not just glioblastoma multiforme. They obviously did not have overall survival data. What is it that PEI saw that caused them to take this regulatory action? If the PEI which is every bit as rigorous as the FDA in its regulatory action could do this, why could the FDA not take a similar course of action. I am curious to hear your reply but unless you can state what the German hospital exemption early access program is, it is pointless to go on with this dialogue.
    Apr 3 08:29 PM | 8 Likes Like |Link to Comment
  • Refuting The Latest Negative Blog On Northwest Biotherapeutics [View article]
    You are entitled to your opinion and could be right on PFS, but there are knowledgeable people who disagree. I provide a link to an article in Neuro-Oncology that states that PFS correlates with OS. I have also provided a link in which a key opinion leader discusses PFS as an endpoint. I would urge everyone to look at those two links.

    As a layman, I take their views seriously. Also some key opinion leaders argue that Avastin should be approved for newly diagnosed glioblastoma despite its not showing any improvement in overall survival in its phase 3 trials. Here is that link http://bit.ly/1dWetac

    Glioblastoma is a very rapidly growing tumor. It can actually push the brain down the brainstem and kill people in that way. That is why newly diagnosed GBM patients are quickly resected and why recurrent GBM patients are quickly resected.

    From my viewpoint and I am not alone, Improvement in PFS is a meaningful clinical outcome in GBM,
    Apr 3 06:32 PM | 7 Likes Like |Link to Comment
  • Refuting The Latest Negative Blog On Northwest Biotherapeutics [View article]
    Adam. I will not soon forget that you have said that I am pumping NWBO and being paid to do so. You seem to back off from that position with these moderate remarks, but my memory is long. Your sensationalist approach to journalism or whatever you call your job offends me. I try to present the positives and negatives as fairly as I can. I see none of that in your work. Your dismissal of the German hospital exemption early access program is an example of this. Your focus on the delay in the DMB delay in reporting efficacy results and implying that this signals problems with the phase 3 trial is also a canard.
    Apr 3 05:55 PM | 20 Likes Like |Link to Comment
  • Refuting The Latest Negative Blog On Northwest Biotherapeutics [View article]
    I have repeatedly heard from the bears that no credible person believes that DCVax-L is effective. This sounds absurd when the Paul Ehrlich Institute (the German equivalent of the FDA) has granted approval for use in not only glioblastoma multforme but also all gliomas, both recurrent and non-recurrent under the hospital exemption ealry access program. Don't respond that this is named patient compassionate use. Here is the link that explains the early access program and how it differs from named patient.

    http://bit.ly/1dW8XVg

    I would point out that PEI looked at the use of DCVax-L in 33 metastatic prostate cancer patients, 11 metastatic ovarian cancer patients and perhaps 20 compassionate use patients in addition to the 20 patients in the newly diagnosed glioblastoma phase 1 trial. This is a total of 84 pateints. In addition, there is an agreement between the FDA and PEI to share pre-registration data. Some have raised the point that the first phase of the DCVax-L trial enrolled 33 patients (perhaps 22 on drug) in 2008 and PEI could look at up to six years of data in these patents. There is no way of confirming this because confirmation would unblind the trial. It is just speculation, but apparently you like to speculate so I thought I would throw this out.

    Not only that but the product is eligible for reimbursement from the German health system.

    DCVax-L undoubtedly has biologic activity if we are to believe PEI. I think I might choose their opinion over yours and Feuerstein's but that's just me.

    I have never guaranteed that the phase 3 trial will succeed. I have seen drugs that later were shown to be effective fail in early clinical trials. The point is this. There is a reasonable basis to believe that the trial will work and if so, it could be a very significant advance in cancer treatment. PEI seems to more than agree with that position.

    By the way, is there any way we can find out who you are and who you represent?
    Apr 3 05:45 PM | 10 Likes Like |Link to Comment
  • Derma Sciences: A Not Well Followed Growth Company With Solutions For Diabetic Foot Ulcers [View article]
    I think this is a very good long term investment and I woud buy it here.
    Apr 2 03:19 PM | Likes Like |Link to Comment
  • Analysis: Northwest Biotherapeutics DCVax-L Germany Approval Under Hospital Exemption Early Access Program [View article]
    Feuerstein has published six negative blogs in the last month and has not (will not) addressed the German hospital exemption early access program other than to imply that it is just the named patient compassionate use program which is much, much more restrictive. My guess is that he is penning negative blog seven as I write. However, with each blog, his influence wanes.
    Apr 2 11:37 AM | 4 Likes Like |Link to Comment
  • Neuralstem: Sizing Up Potential Key Events Of 2014 [View article]
    We all know that their is uncertainty from drawing conclusions on so few patients. However, this is ALS and for a disease that inexorably progresses, it is impossible to dismiss the conclusion that they are helping some patients in a dramatic way. Wall Street is oblivious and regards this as a science project.
    Mar 31 09:17 AM | 3 Likes Like |Link to Comment
  • Analysis: Northwest Biotherapeutics DCVax-L Germany Approval Under Hospital Exemption Early Access Program [View article]
    The information is anecdotal. The trading activity of hedge funds is not publicly available.
    Mar 21 10:35 AM | Likes Like |Link to Comment
  • Analysis: Northwest Biotherapeutics DCVax-L Germany Approval Under Hospital Exemption Early Access Program [View article]
    I think that Feuerstein has minimized the importance of Germany and DCVax Direct while sounding all kinds of alarms that the phase 3 trial is in trouble perhaps because the data gathering has been screwed up or DCVax-L is a placebo, This is a red herring and a ridiculous argument to make with no supporting evidence of any kind, but as would be expected it has caused uncertainty for investors. Curiously, there always seems to be a great deal of shorting shortly after F-stein articles. The DMB will recommend continuation of the trial after the efficacy analysis is completed which completely refutes the F-stein argument. However, he will then shift to some other issue, yet to be determined, that will be presented as a dire negative.
    Mar 20 11:19 AM | 3 Likes Like |Link to Comment
  • Analysis: Northwest Biotherapeutics DCVax-L Germany Approval Under Hospital Exemption Early Access Program [View article]
    Wall street traders indicate to me that there is a bear raid going on in which certain hedge funds are acting in concert to move the price down. This is a tactic frequently used against small biotechnology companies.
    Mar 20 10:05 AM | 3 Likes Like |Link to Comment
COMMENTS STATS
870 Comments
1,366 Likes