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  • How Successful Was The Neuralstem Phase II Trial? [View article]
    No. They must rule out harm to nonresponders. Will have to provide improved identification of characteristics of responders - which this ph2a is likely to have provided. Think of it like a cancer drug trial. If half population improves because of the drug, but half is actively harmed by the drug, company would need to be able to dramatically improve safety of all participants before FDA supports trial advancement.
    Mar 17, 2015. 06:31 PM | 2 Likes Like |Link to Comment
  • How Successful Was The Neuralstem Phase II Trial? [View article]
    This was phase 2a. Next is controlled 2b. Too many questions at this time for the company to consider commercialization. The criteria specific to their responder pool must be identified first. Without this criteria, they will have difficult time creating successful ph3.
    Mar 17, 2015. 06:26 PM | 1 Like Like |Link to Comment
  • How Successful Was The Neuralstem Phase II Trial? [View article]
    And earliest possible intervention after diagnosis is one of the stated responder identification criteria affirmed by this study and mentioned by Garr.
    Mar 17, 2015. 06:20 PM | 1 Like Like |Link to Comment
  • How Successful Was The Neuralstem Phase II Trial? [View article]
    And microscopic evaluation of the data this trial has accumulated will hopefully strengthen responder identification criteria.
    Mar 17, 2015. 06:19 PM | Likes Like |Link to Comment
  • Synthetic Biologics: A Speculative Small Cap Packed With Power [View article]
    Ballantyine with 200k shares and Riley with 350k are contracted to graduated vesting plan. You may believe they need to buy more, but their vested benefit will leave them wealthy. The 10 year vesting period indicates commitment to company growth.
    Feb 28, 2015. 05:58 PM | 1 Like Like |Link to Comment
  • Synthetic Biologics: A Speculative Small Cap Packed With Power [View article]
    Teva will need its next gen push. This trimesta/copax combo is limited to its specific target population. For the rest who are ineligible for it, Teva will try to maintain dominance thru next gen push. But the next gen will not push the combo product away from its appropriate population. Wouldn't make good business sense to not offer the most effiacious and patent secured med to a large available population.
    Feb 19, 2015. 12:28 PM | 3 Likes Like |Link to Comment
  • Synthetic Biologics: A Speculative Small Cap Packed With Power [View article]
    Trevor, if Teva is unable to stop the generic form of copaxone from being produced and brought to market, then trimesta may become even more important. They may not be willing to pass up holding the combo patent for trimesta/copaxone. Doing so would allow them to hold on, exclusively, to a large percentage of the present copaxone-treated population for many years.
    Feb 18, 2015. 05:22 PM | 1 Like Like |Link to Comment
  • Synthetic Biologics: A Speculative Small Cap Packed With Power [View article]
    SYN is a rare opportunity in this space. The management and pipeline are excellent. Excepting legacy trimesta, the pipeline is constructed for rapid development with well identified target populations. Good investment in high risk space.
    Feb 10, 2015. 05:27 PM | 5 Likes Like |Link to Comment
  • Idera Pharmaceuticals Going Into 2015 [View article]
    I too remain very bullish on IDRA. When this company runs, it runs hard. Investors have many opportunities to sell on spikes and buy back in lower. Building position this way and taking original $ off the table is a helpful habit - keeps the biotech long afloat if the worst happens. Good luck and thanks for a great summary on this excellent little biotech company.
    Dec 22, 2014. 06:52 PM | Likes Like |Link to Comment
  • Why Neuralstem Has Plenty Of Upside In The Short Term [View article]
    Study is not complete for 6 months after treatment of final patient. Months of observational post-tx data yet to be accumulated. Study complete after this criteria met - then data lock and evidence review will occur, as well as submission of study results to FDA. All they give the FDA during the study are updates, mostly safety related. They have not locked and sent an incomplete study that still has 6 months to go. For clarification, refer to Aug 2014 investor presentation.
    But - they may indeed provide us with some updates prior to close of study, given that it is open label and some cohorts have gone public.
    " The trial will conclude after an observation period of six months," said Karl Johe, PhD, Neuralstem's Chairman and Chief Scientific Officer. - See more at: http://bit.ly/1u1WuEv"
    Sep 3, 2014. 09:05 PM | 1 Like Like |Link to Comment
  • Why Neuralstem Has Plenty Of Upside In The Short Term [View article]
    The preclinical and human research process is the accumulation of that efficacy data we all desire. No choice but to be patient as the stem procedure and novel molecule move thru trials and give us that info. As far as scalability goes - you would have to look back in pr's to a 2012 interview - Johe described in depth the size of both their library and their production capacity. For the cells used in the ALS procedure - he said they presently have enough for 1.7 billion patients using baseline of 20 injections of 300k cells per each injection, and this is from dividing just one cell. So...production very unlikely to be problematic. And their cell library is huge.
    As to results timing for ALS ph2 - last patient txd early Aug. End of post-surgical 6 month observational period will signal true close of trial so that brings us up to early Feb 2015. Then results review and data crunch, optimistically 8 weeks but realistically 12 is more likely. Brings us to May 2015.
    Patience...not my strong suit but this sector demands it and this company deserves it, imho.
    Good luck!
    Aug 26, 2014. 09:21 PM | 2 Likes Like |Link to Comment
  • An Early Valuation Of Neuralstem's NSI-189 For MDD [View article]
    Well - I am hoping to like it in the future with this new drug. We'll see. As for liking it right now, only in the most serious cases and then with the recognition that modern treatment can be lifesaving for such acuity. To generalize beyond that to my entire practice is an emotional projection on your part, an interpretation of our discussion here in which you have drawn an erroneous conclusion with no real supportive data.
    Jun 29, 2014. 09:40 AM | Likes Like |Link to Comment
  • An Early Valuation Of Neuralstem's NSI-189 For MDD [View article]
    "The good thing here with CUR is that is reverses some of the damage to the brain-hippocampus- caused by the anti depressants. " We don't know if NSI-189 can reverse hippocampal damage yet. And while the current treatment selection of AD's for depression isn't the greatest, one positive is that SSRI treatment does appear to preserve hippocampal volume. Recurrent depressive episodes are shown to damage that area and (perhaps due to their anti-inflammatory effect) SSRI treatment is proving out to preserve the hippocampus from volume loss secondary to depression for chronic sufferers. Stimulation of neurogenesis is what makes antidepressant therapy efficacious. Just want to respond to your untrue statement that AD's cause such damage. Chronic depression causes such damage and AD treatment of chronic depression is proving to protect the brain from literal shrinking. But it takes a long time. A hope for NSI-189 in humans is that it will prove to be more targeted in this protective action for the hypothalamus and will preserve and restore much more quickly than current options.
    http://bit.ly/1iQ9iuZ
    http://preview.tinyurl...
    http://1.usa.gov/1iQ9iv1
    Jun 28, 2014. 09:31 PM | 1 Like Like |Link to Comment
  • Neuralstem NSI-189 Abstract Teases At Potential Greatness [View article]
    Their press releases can be counted. There were two releases announcing conferences and 2 announcing results this past month. You believe they 'milked', with 'multiple announcements of the same results'. That appears to be an exaggerated statement. They have planned on a ph2 for a prolonged period, making statements about their commitment to a phase 2 as long as a year ago, repeated consistently through their June conference. Yet you make this statement "We have been told NSI-189 was going to be sold OR the company might proceed on their own." They have not changed their narrative and your statement indicates lack of understanding or just lack of dd. These are not emotionally based points, they are just information based from CUR statements. Your post referred to trust/'getting a sense' followed by projected application of motivation evidenced by statement management may be 'milking' with repeated prs. Those are emotionally based sentiments and prove to be not based on the information the company has provided. Perhaps you are referring to statements made by other investors? Management did not state that they were looking to make a deal with NSI-189 this June. They have been consistent in verbalizing plan to carry out ph2 and staying open to partnership talks, but they did not make a statement of desire to sell prior to ph2. If you read this post, you will hopefully see that I am not asking you to agree. I am not trying to convince you of anything except the difference between a statement based on emotion vs an information based statement. Nothing wrong with selling, ever. But you have twice used faulty info to support your decision, and my responses are constructed to clarify with information given by the company, which can be verified simply by going to the company site.
    Jun 28, 2014. 12:57 PM | Likes Like |Link to Comment
  • An Early Valuation Of Neuralstem's NSI-189 For MDD [View article]
    Or do the numbers increase because the mental health system has been dismantled and there is no system of ongoing care and assistance for them, resulting in higher need for acute episodic treatment?
    Jun 28, 2014. 12:17 PM | 1 Like Like |Link to Comment
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