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  • Discovery Laboratories: Surfaxin Launch Has Been Slow, But Clinical Trials Of Aerosurf Are Beginning At Last [View article]
    I am writing a report that will be published on my website SmithOnStocks.com withing two weeks. The stock is down in anticipation of an equity offering. Your assessment is the same as mine.
    May 19, 2015. 08:24 AM | Likes Like |Link to Comment
  • Discovery Laboratories: Collaboration With Battelle Is Validation Of Aerosurf's Potential By A Sophisticated Third Party [View article]
    The data on the phase 2 a trial must be viewed in the context that it was a single dose trial whose primary goal was to determine if the Aerosurf can be safely delivered as a single dose. The answer is yes and that is a positive. There were signals of efficacy based on lowering of FiO2 and CO2 in the twelve hours after administration. These need to be conformed in phase 2b. Based on this data, the results were quite encouraging. The stock is getting creamed in anticipation of an offering.
    May 15, 2015. 02:36 PM | Likes Like |Link to Comment
  • Northwest Bio: FDA Panel Recommendation On Amgen's Cancer Vaccine Is Significant For DCVax-L And DCVax Direct [View article]
    I recently recommended IMUC.

    http://bit.ly/1GRlEhr
    May 2, 2015. 10:41 PM | 2 Likes Like |Link to Comment
  • Northwest Bio: FDA Panel Recommendation On Amgen's Cancer Vaccine Is Significant For DCVax-L And DCVax Direct [View article]
    I really don't think that the FDA reads Feuerstein's blogs and takes them into consideration in their regulatory decisions.
    May 2, 2015. 08:59 AM | 8 Likes Like |Link to Comment
  • Northwest Bio: FDA Panel Recommendation On Amgen's Cancer Vaccine Is Significant For DCVax-L And DCVax Direct [View article]
    This is eloquently written and we are in alignment in our thinking.
    May 2, 2015. 08:56 AM | 3 Likes Like |Link to Comment
  • Northwest Bio: FDA Panel Recommendation On Amgen's Cancer Vaccine Is Significant For DCVax-L And DCVax Direct [View article]
    This is a good point in contrast to your previous comments. None of us know the answer to this question. However, natural dendritic cells seem to have somehow g figured it out.
    May 1, 2015. 07:54 PM | 7 Likes Like |Link to Comment
  • Northwest Bio: FDA Panel Recommendation On Amgen's Cancer Vaccine Is Significant For DCVax-L And DCVax Direct [View article]
    This makes no sense. Could you rephrase? What comparison are you referring to?

    Do you believe that proton pump inhibitors, H2 antagonists, ARBS, statins etc which have recorded multli-billion dollars of sales and are quite safe are ineffective. I think you are getting in over your head.
    May 1, 2015. 04:08 PM | 11 Likes Like |Link to Comment
  • Northwest Bio: FDA Panel Recommendation On Amgen's Cancer Vaccine Is Significant For DCVax-L And DCVax Direct [View article]
    I think that if you read the article I go over the mechanism of action for Tvec and anyone who understands dendritic cell vaccines would not draw the conclusion that I think the products have similar mechanisms of action nor manufactruing process. In fact, one is autologous cell manufatruing and the other isn't. The commonality is that they are trying to induce a systemic immune response. The panel appears to appreciate that this makes cancer vacines a promising new approach in immuno-oncology.

    From a clinical standpoint, I make two primary points. The first is that the panel did not insist on OS as being the basis for approval. This is important for DCVax-L as the primary endpoint is PFS with OS as a secondary endpoint. Importantly, Tvec showed a strong trend on OS with a 4.4 month improvement over the GM-CSF control arm, but missed statistical significance at p=0.051. I also feel that PFS is a very important endpoint in glioblastoma because of the close correlation with OS.

    There are other points that I also make in the article which I won't go over. However, I will take this as a learning moment as you explain why these observations are jokes.
    May 1, 2015. 02:59 PM | 12 Likes Like |Link to Comment
  • Northwest Biotherapeutics: Encouraging Survival Results In 51 Glioblastoma Multiforme Patients [View article]
    One of my subscribers said that NWBO is now Woodford's 25th largest position in a $5 billion portfolio. He Certainly has $65 million invested from the two equity deals plus open market purchases that bring his investment to well over $80 million. This signifies enormous conviction on the part of someone who has done an enormous amount of due diligence or it is an act of lunacy. One would not expect lunacy from someone with his investment credentials.
    Apr 5, 2015. 08:51 AM | 8 Likes Like |Link to Comment
  • Northwest Biotherapeutics: Encouraging Survival Results In 51 Glioblastoma Multiforme Patients [View article]
    This was meant for the Bohsie comment.
    Apr 3, 2015. 08:37 AM | Likes Like |Link to Comment
  • Northwest Biotherapeutics: Encouraging Survival Results In 51 Glioblastoma Multiforme Patients [View article]
    I agree with you. I think that manipulation of dendritic cells is the best way of bolstering an immune response against cancer. This is how the body triggers a broad based response of effector and regulatory T-cells and B-cells. It also brings the innate immune system into play. This just makes more sense to me as a layman than focusing on just one component of the active or innate immune response.
    Apr 2, 2015. 10:54 AM | 3 Likes Like |Link to Comment
  • Northwest Biotherapeutics: Encouraging Survival Results In 51 Glioblastoma Multiforme Patients [View article]
    They were patients who were candidates for the phase 3 trial. However, their cancer progressed making them ineligible before they could be entered in the trial. They were then entered into a compassionate use arm and treated in the same way as if they were enrolled. The difference is that they will not be included in the final statistical analysis.
    Apr 2, 2015. 10:49 AM | 2 Likes Like |Link to Comment
  • Northwest Biotherapeutics: Encouraging Survival Results In 51 Glioblastoma Multiforme Patients [View article]
    Autologous cell manufacturing is a very different endeavor than manufacturing small molecules or monoclonal antibodies. It requires dedicated facilities and logistical infrastructure that is very different and very expensive.
    The two continent manufacturing capability will pay massive dividends to shareholders if DCVax-L is approved.
    Apr 2, 2015. 10:46 AM | 5 Likes Like |Link to Comment
  • Northwest Biotherapeutics: Encouraging Survival Results In 51 Glioblastoma Multiforme Patients [View article]
    My thoughts are similar to yours.
    Apr 2, 2015. 10:31 AM | 4 Likes Like |Link to Comment
  • An Expert's Opinion On Neuralstem's Phase 2 Results [View article]
    Topline data is by definition an overview of the trial and not a complete analysis. The reason is that the preparation of a paper on an important clinical trial is extremely important to the investigators in enhancing their reputations and advancing their careers. These paper are usually presented at a major medical conference and then published in a peer reviewed journal, If the full data set is presented before a conference it will be rejected. As much as Neuralstem might want to release more data or perhaps some explanation of what went on in the non-responders, it must remain silent. I have a good professional relationship-analyst to company management- with CEO Richard Garr. He has not returned my calls since this data was published.
    Apr 1, 2015. 11:18 AM | 4 Likes Like |Link to Comment
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