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  • InVivo Therapeutics - Reality Distortion Or Reformation? [View article]
    What I tried to convey in my piece (which fell on some deaf ears) are the following observation that relate to your points:

    1. The significance of the results from the monkey studies, while theoretically could be classified as 'promising', were greatly exaggerated by Reynolds.
    - The data (which was not included in the investor presentation) clearly demonstrates that all monkey subjects were improving, including controls. We do not know how representative the selective monkey videos of the totality of the data.
    - The scale used in those analyses was a non-validated InVivo developed scale.
    - The presented data was lacking basic statistical analysis.
    - The most recent, largest, monkey study has never been presented.

    2. While I doubt this company will seek to uplist any time soon, I think it should be the least of anyone’s concern at this point in time. While trading on the bulletin board this stock attained both liquidity and a significant market cap of ~ $400 million. Uplisting is no panacea for shareholder value, only a technical manoeuvre.

    3. Somehow Reynolds was able to instill in everybody’s minds the notion that the scaffold and hydrogel as well are some extraordinary breakthroughs that will be immediately evident once entering clinical testing. Neither are! And obviously both will be subjected to rigorous testing.

    4. That is a question I think investors and their lawyers should focus on. When did FDA communicate the required HDE protocols to NVIV? Needless to say Reynolds in his public presentations did not allude to the possibility of a 5 year development program. You see, I have heard concerns that InVivo’s strategy in SCI could theoretically cause compression damage in surgical patients. FDA seems to have that same worry, hence the staggered approach.

    5. Unlike Reynolds assertions, let alone others, I do not believe that slight improvements in complete SCI patients could be attributed to the scaffold product in the absence of a robust controlled study. The literature documents that about 20% of complete SCI patients to improve following injury (happy to provide references). I see no shortcuts for the company and change in protocol.

    6. I think recent events begin to suggest that the reasons to Reynolds’ departure are more complex than investors’ are being led to believe.

    7. I sure hope for the investors that are still in the stock that this CEO remains in place. I cannot see anyone wanting to sign up to deal with the issues that have been created by the prior CEO which I suspect will have long-term ramifications.

    8. I think remaining investors should continue to be worried by what has transpired. I am doubtful you will get much clarity from management.

    Any investor in NVIV needs to realize that the path to potential cashflows is at least 5 years - pilot study and efficacy trial included. Since the efficacy trial will have a control arm, investors need to ask themselves what is the actual clinical risk in this technology and will it demonstrate benefit over standard of care. I stated my views in the past, and I see the risks as high. But in fairness, if clear efficacy is demonstrated (sometimes in 2018-2019), NVIV could be worth more than it is now (taking into account the required dilutions due to required financings that will be necessary to move things along).
    Sep 1, 2013. 08:11 AM | Likes Like |Link to Comment
  • InVivo Therapeutics: A Reality Distortion Field [View article]
    I do not know what those governance issues were. The company was not transparent in relation to those. Instead an abrupt resignation of the CEO.

    As a shareholder you should be up in arms about the complete absence of disclosure on the part of NVIV.
    Aug 26, 2013. 12:14 AM | 1 Like Like |Link to Comment
  • InVivo Therapeutics: A Reality Distortion Field [View article]
    Absolutely. There is a natural course of recovery in SCI. Any treatment effect needs to demonstrate benefit over SOC recovery. If you think these patients will get up and run you are dreaming.

    But Kudos to InVivo for making so many of you believe in that possibility. That is what I find distasteful in this company.
    Aug 25, 2013. 12:09 PM | 1 Like Like |Link to Comment
  • InVivo Therapeutics: A Reality Distortion Field [View article]
    What debate are you talking about. PMA requirements and guidelines are not debatable.
    Aug 25, 2013. 11:54 AM | 1 Like Like |Link to Comment
  • InVivo Therapeutics: A Reality Distortion Field [View article]
    Why has the company not included such basic statistical analysis on the data then in their presentation of it?

    To allow for human clinical trials no demonstration of efficacy is required.

    InVivo used their own scale for measuring recovery. A non-validated scale. No I do not agree that 2 point recovery is meaningful. Much of the data can be explained as a random walk based on cross study variability.
    Aug 25, 2013. 11:23 AM | 1 Like Like |Link to Comment
  • InVivo Therapeutics: A Reality Distortion Field [View article]
    PMA applications have specific requirements that include the demonstration of effectiveness. The HDE path does not allow for a PMA approval. Those studies will require at least 5 years of development.
    Aug 25, 2013. 11:20 AM | Likes Like |Link to Comment
  • InVivo Therapeutics: A Reality Distortion Field [View article]
    It should not be ignored. But at the same time it cannot be used as a supposed proof of efficacy. I am certain the standard error bars would demonstrate no statistical significance on separation.

    The company, however, and specifically Reynolds was implying extraordinary efficacy, which is not demonstrated in these graphs and in this model . It is these assertions by him that led to the company's $400MM value.
    Aug 25, 2013. 11:02 AM | 1 Like Like |Link to Comment
  • InVivo Therapeutics: A Reality Distortion Field [View article]
    Here you go. You don't need to rely on myself or Napodano:
    From FDA's most recent guidelines: Guidance for Industry and Food and Drug Administration Staff Humanitarian Use Device (HUD) Designations issued January 24, 2013:

    "FDA approval of an HDE application authorizes the applicant to market the device. This marketing approval issubject to certain profit and use restrictionsset forth in section 520(m) of the FD&C Act, 21 USC § 360j(m)."
    http://1.usa.gov/17ebdyW

    From section 520(m) of the FD&C Act, 21 USC § 360j(m):

    "Except as provided in paragraph (6), no person granted an exemption under paragraph (2) with respect to a device may sell the device for an amount that exceeds the costs of research and development, fabrication, and distribution of the device"
    http://bit.ly/17ebeTE
    Aug 25, 2013. 09:38 AM | 1 Like Like |Link to Comment
  • InVivo Therapeutics: A Reality Distortion Field [View article]
    You seemed to have erased your prior comment, snake oil and all...so here it is, no math required.

    You obviously are resisting reading the details I provided above. Here, I will help you. As per HDE guidelines (I provided a reference in the hyperlink):

    "Sponsors are limited to recovering the cost of research and development, manufacturing and distribution. They are not permitted to make a profit on the sale of the HUD, if the device is sold for more than $250."
    Aug 24, 2013. 11:45 PM | 1 Like Like |Link to Comment
  • InVivo Therapeutics: A Reality Distortion Field [View article]
    "Allowing someone to publish an article does not make them a credible source..."

    I fully agree with that statement. I disclosed the fact that I am short the stock, coupled with my analysis for the reasons I believe the company to be significantly overvalued.

    You are entitled to ignore my analysis and put a bid under the stock price. I can guarantee Reynolds will still put his shares on the offer in days to come and will appreciate your support providing him with much needed dwindling liquidity.
    Aug 24, 2013. 10:52 PM | 2 Likes Like |Link to Comment
  • InVivo Therapeutics: A Reality Distortion Field [View article]
    Allowing a company to initiate human clinical trials says nothing about its efficacy. Let alone its ultimate safety. How many drugs have been pulled off the market subsequent to their full FDA approval?
    Aug 24, 2013. 09:21 PM | 1 Like Like |Link to Comment
  • InVivo Therapeutics: A Reality Distortion Field [View article]
    I fully disclosed my position along with arguments supporting my opinions. There is nothing wrong nor illegal about that.
    Have you ever complained about the fluff SA pieces pumping this stock with misleading information?
    Aug 24, 2013. 09:16 PM | 1 Like Like |Link to Comment
  • InVivo Therapeutics: A Reality Distortion Field [View article]
    You view a sell-side analyst working for an I-bank getting paid by NVIV as credible? give me a break. Aegis did their last deal.
    Aug 24, 2013. 09:06 PM | 1 Like Like |Link to Comment
  • InVivo Therapeutics: A Reality Distortion Field [View article]
    That on top of collecting > $1MM annual salary while serving as both CEO and CFO. Unheard of.
    Aug 24, 2013. 09:05 PM | 1 Like Like |Link to Comment
  • InVivo Therapeutics: A Reality Distortion Field [View article]
    Have you ever complained about the CEO's misleading statements regarding its technology leading to the stock price hitting $6 a month ago? All that, while he has been selling millions of dollars worth of stock?
    Aug 24, 2013. 09:02 PM | 1 Like Like |Link to Comment
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