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  • 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 | 2 Likes Like |Link to Comment
  • Northwest Biotherapeutics: Encouraging Survival Results In 51 Glioblastoma Multiforme Patients [View article]
    Without the strident efforts of investors who were shorting (manipulating) the stock, I think that they would have been able to take the course you suggest. I can't assure you that DCVax-L will be successful in its phase 3, but I think that the data they have created justifies the allocation of capital necessary to determine if that is so. I can argue that their data is as compelling as that of companies like Juno and Kite which have been showered with cash.
    Apr 1, 2015. 08:12 AM | 4 Likes Like |Link to Comment
  • An Expert's Opinion On Neuralstem's Phase 2 Results [View article]
    This is a point that I have made. In the case of stem cell treatment, the FDA has exercised very careful oversight. This leads me to think that if there was a serious problem with the surgery in the non-responders that they would have quickly put a clinical hold on the trial. I would also question why Eva Feldman was so publicly enthusiastic about the results. I remain unable to come up with a reasonable hypothesis about the poor responses in non-responders. However, these factors raise the possibility that there is a reasonable explanation.
    Apr 1, 2015. 07:23 AM | Likes Like |Link to Comment
  • Northwest Biotherapeutics: Encouraging Survival Results In 51 Glioblastoma Multiforme Patients [View article]
    You are correct that manufacturing capital expenditures being included in R&D expense.
    Mar 31, 2015. 05:37 PM | 4 Likes Like |Link to Comment
  • Northwest Biotherapeutics: Encouraging Survival Results In 51 Glioblastoma Multiforme Patients [View article]
    There is a good chance that NWBO will announce a trial of one or perhaps both DCVax products with checkpoint inhibitors.
    Mar 31, 2015. 05:34 PM | 2 Likes Like |Link to Comment
  • Northwest Biotherapeutics: Encouraging Survival Results In 51 Glioblastoma Multiforme Patients [View article]
    Northwest would have been unable to complete clinical trials and probably would have gone bankrupt without Cognate being willing to take stock in lieu of cash. The Cognate balance sheet is so laden with Northwest Biotherapeutics stock that Cognate's existence may also hinge on the success of DCvax-L and DCVax Direct.

    AF and bloggers who appear to work for hedge funds shorting the stock have tried to create the appearance of sinister interactions between the two entities. It is standard operating procedure for them to create straw man arguments like this.

    It is also head scratching to hear AF argue that NWBO shareholders are being victimized by NWBO paying for services with stock and diluting existing shareholders. This is at the same time that he maintains that DCVax products are no more effective than grapefruit juice. Correct me if I am wrong, but wouldn't this mean that NWBO stock would be worthless. For him, inconsistencies of arguments are not a problem.
    Mar 31, 2015. 02:35 PM | 8 Likes Like |Link to Comment
  • NovaBay: Phase II Topline Results For Auriclosene In UCBE Are Very Encouraging (NovaBay, $1.57) [View article]
    A good 2 cents.
    Mar 31, 2015. 12:42 PM | Likes Like |Link to Comment
  • Northwest Biotherapeutics: Encouraging Survival Results In 51 Glioblastoma Multiforme Patients [View article]
    The 60 Minutes piece on the use of the polio virus to potentially create an immune response against glioblastoma had an interesting comment. It said that the size of the tumor can double in two to three weeks in some patients. This rapid growth can be devastating in the confines of the skull.
    Mar 31, 2015. 12:36 PM | 5 Likes Like |Link to Comment
  • Northwest Biotherapeutics: Encouraging Survival Results In 51 Glioblastoma Multiforme Patients [View article]
    In the phase 3 trial, all patients on standard of care are switched to DCVax-L if they progress.
    Mar 31, 2015. 12:33 PM | 3 Likes Like |Link to Comment
  • An Expert's Opinion On Neuralstem's Phase 2 Results [View article]
    This analysis may make the decline in ALSFRS-r look less negative. However, it patients starting at this baseline level of ALSFRS-r are dying in the interval of nine months, it may be a big problem.

    I don't know how to explain these results and like everyone else, I am concerned about the trend for ALSFRS-r in non-responders. I fall back on the support for the treatment shown by three independent and highly respected opinion leaders that the results of the trial are encouraging and warrant continued development and the Company's statement that it will be starting a 50 patient randomized phase 3. This suggests to me that there is an explanation for the non-responders, but I don't know what it is.

    The Company is in the difficult position of not being able to talk in detail about results until Eva Feldman publishes in a peer reviewed journal. This leaves us all swinging in the wind. Meanwhile the usual gang of hedge funds are aggressively shorting (manipulating) the stock. This builds character.
    Mar 31, 2015. 11:25 AM | 3 Likes Like |Link to Comment
  • Northwest Biotherapeutics: Encouraging Survival Results In 51 Glioblastoma Multiforme Patients [View article]
    In my opinion, it would be a mistake to stop at the interim analysis even if the primary endpoint is reached. NWBO has done an excellent job in stratifying this trial e,g for methylations statu. DCVax-L, if it is successful in phase 3 and this is not a given, will not be equally effective in all patient groups. It is in everyone's best interests to gather as much information as can possibly be gleaned from the phase 3. This will allow for the best possible strategy for treating ndGBM.
    Mar 31, 2015. 11:12 AM | 1 Like Like |Link to Comment
  • Northwest Biotherapeutics: Encouraging Survival Results In 51 Glioblastoma Multiforme Patients [View article]
    This is an event driven trial so that it is makes it difficult to determine when the number of events is reached that is needed to stop the trial and trigger the analysis. I am guessing topline results in 1H, 2016.
    Mar 31, 2015. 11:06 AM | Likes Like |Link to Comment
  • How Successful Was The Neuralstem Phase II Trial? [View article]
    The point you are not taking into account is that all other trials involving other drugs to my knowledge have had the goal of reducing the rate of decline in ALSFRS-r. In the 7 responders of the phase 2a and 5 in phase 1, we have seen stabilization, a slight increase or a slight decrease in ALSFRS-r. This is the striking effect of this data set. By my calculation, there were 20 patients in the phase 1 and 2 trial that could reasonably have been expected to have a response out of the 30 patients in both trials. See my report on this http://bit.ly/1Cri5Ny

    This is a 60% response rate in likely responders and 40% for any patient receiving the drug.
    Mar 22, 2015. 12:35 PM | 1 Like Like |Link to Comment
  • An Expert's Opinion On Neuralstem's Phase 2 Results [View article]
    I find it interesting that AF is recommending Brainstorm while trashing Neuralstem. I am perplexed by the Brainstorm approach of using mesenchymal adult stem cells as opposed to adult neural stem cells like Neuralstem as are some of the key opinion leaders I rely on. To the layman like myself, it would appear that neural stem cells which have the ability to differentiate into other cells of the central nervous system and also secrete neurotophic factors that nourish CNS cells would be a more promising approach than using mesenchymal adult stem cells from the bone marrow. Their ability to transdifferentiate into CNS cells is controversial as is the idea that the trophic factors they secrete can nurture CNS cells. Perhaps AF can enlighten me on this.
    Mar 21, 2015. 08:22 AM | 5 Likes Like |Link to Comment
  • An Expert's Opinion On Neuralstem's Phase 2 Results [View article]
    NSI-189 is a fascinating drug that works very differently from any CNS agent ever developed in that it appears to be able to regrow neurons in the hippocampal region of the brain which only recently was found to contain adult stem cells. I am extremely interested in this drug but we will not likely see phase 2 data until sometime in 2016.

    I wrote a detailed report on the phase 1 results for my subscribers. The link is http://bit.ly/1FjvPui
    Mar 21, 2015. 08:10 AM | 4 Likes Like |Link to Comment
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