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Neuralstem, Inc. Message Board

  • grantdutchy grantdutchy Sep 23, 2013 7:07 AM Flag

    FDA Approval NIS-189

    I hear CUR is not going to get FDA approval for NIS-189. Does anybody know anything about that?

    Sentiment: Hold

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    • Who teach you how to lie?

    • #1 It is actually called "NSI-189" (not NIS-189).
      #2 Neuralsteim is currently conducting an FDA approved phase 1b clinical trial - so what exactly is it that you think the FDA is not going to approve? As far as I know there is nothing else that Neuralstem has applied for related to this compound - so please share your source and some specifics. (As far as I know, all other indications like Alzheimer, stroke, traumatic brain injury, etc. are waiting for the results of the current trial).

      Your post seems like you are short and need to try to manipulate the price to get out at a lower price, or you want to be long with a lower basis. Which is it?

      Here is the information from the company's website about the current 1b trial:

      "Neuralstem’s NSI-189 Major Depressive Disorder Trial

      The NSI-189/MDD trial is a randomized, double-blind, placebo-controlled, multiple-dose escalating trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamic effect of NSI-189 in the treatment of major depressive disorder. Phase Ia, initiated in February 2011 and completed in October 2011, tested escalating doses of single administration of NSI-189 in healthy normal volunteers. Phase Ib, approved by the FDA in December 2011 and commenced in June 2012, tests the safety of escalating doses of NSI-189 for 28 daily administrations in 24 depressed patients. The FDA approved dosing of the third and final cohort of depression patients in April 2013. Neuralstem is expected to complete the entire Phase I NSI-189/MDD trial in the second half of 2013.

      In preclinical work, Neuralstem’s lead pharmaceutical compound, NSI-189, demonstrated clear evidence of increased hippocampal volume in animals with a model of depression. Neuralstem believes NSI-189 has the potential to reverse the hippocampal atrophy associated with major depressive disorder and other related disorders, and to restore fundamental brain physiology"

      Sentiment: Buy

      • 2 Replies to whatchutalkingbout
      • Exactly.... This is just the new tactic of soft bashing. Present some garbage and hope that people will say "really, it is not going to get approved" The funny thing is they aren't even smart enough to do it well. Anyone in their right mind would say, where did you hear this. In addition, if he had really heard this news he would have said "according to so and so NS-189 is not going to be approved" They aren't even smart enough to do their soft bashing well.


      • Thank you for taking the time to mitigate the impact of disinformation on this board. It would be nice if the only thing investors had to do to validate the long position is due diligence and patience. People with political agendas should move to a board where politics provide the main course of discussion and day traders should simply trade the natural cycle of investment. No need to trade in false information. Thanks again for responding to yet another attack on the integrity of the investment community.

2.01-0.01(-0.50%)Mar 27 4:01 PMEDT