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InVivo Therapeutics Holdings Corp. Message Board

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  • analystnueve analystnueve Oct 13, 2012 11:10 AM Flag

    the fda

    My only disagreement is that I believe if... no when the FDA issues its approval, this will be the starting gate to success. The hurdles are minimal. Why? The procedure WORKS in monkeys, and has been proven SAFE in monkeys. The upcoming human trials are more about safety than efficacy. No complications = success. Obviously functional recovery = success as well. Greater success. And the threshold is quite low. The company has been saying for months, "if we can spare just 10 percent..." Does everybody realize what this means? The monkey studies were overwhelmingly successful and the human trials have this very low bar on efficacy. There is good reason for this lower bar to be in place because the monkey injuries were surgical and not traumatic. Still, ANY functional improvement in humans will be huge. Safety is pretty much a given since the material has been used in sutures for many years.

    So, we get a sizable step up just from FDA approval. It will sustain because shortly thereafter will be the news of human trials commencing. Then it goes up again. However, once trials begin, after peaking we could see a little pullback as some may hedge slightly in case of less than expected results. HOWEVER, if results are excellent, this goes to the stratosphere. Why?? Well, as a medical device company, the pathway is shorter and easier than drug from a pharma! And the HUD/HDE pathway makes that clear. They would be able to move into small revenue generation quickly. From there, as additional safety and efficacy data are collected, the FDA upgrades its approval beyond HDE and once in full scale market, InVivo Therapeutics gets to play in the $10 Billion acute SCI market.

    By this time, the hydrogel formulations will be ready to come to market in both CNS and Peripheral indications. The peripheral market was estimated at $20 Billion. Then comes the chronic SCI market by the time the scaffold and/or hydrogel with stem cells is approved. Happy New Year 2018.
    (Can you believe there were some skeptics back in 2012?!)

    Sentiment: Strong Buy

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    • Hey kool, if fda gives the approval we are looking at putting a custom made patch into the spine area of 5 patients. Its either going to work or it isn't. If it works we should know within a couple months of the first patient being treated. If any of the 5 patients gets better it works at least 20% of the time. If all 5 get better it works 100% of the time. Its not like drug trials that take a few years to complete. The scaffold is either going to allow reconnection of signals or its not. Just my speculation but i dont think this is going to drag out like all the other regenerative medicine companies im watching are. By the way i see your into some pretty neat companies but i didn't see actc listed. You might want to check them out if you haven't already. Im only in gern,nviv,actc, and cur. All are long term holds cause im in this till major inflection points are reached. If i had more money to spread arround id get into psti but i dont know much about the others. Steve

      Sentiment: Strong Buy

      • 1 Reply to jssflash
      • ACTC is interesting - macular degeneration has major $ potential. And they just got financing that will carry them forward for some time. It's worth a shot. Again, speculative. I do believe that stem cells will play a major role in the future of medicine. PSTI is another such bet. I like it a lot and increased my position recently. I think partnership activity can drive both these companies in near term. SGMO "may" have functional cure for HIV. They're in clinical trials. LXRX has a diabetes drug LX4211 that looks like a real winner. ISIS has a huge pipeline and patent portfolio. It goes before FDA advisory panel this coming week for drug mipomerson which treats homozygous familial hypercholesterolemia. VICL DNA delivery technology has some interesting trials going on, including Allovectin in Phase III for metastic melanoma and TransVax, which is in Phase III clinical trials to protect against CMV infection after stem cell transplants. KOOL I'm not too keen on - I just think it's cheap, - the company should be put up for sale. PSDV is very small market cap. It's focused on drug delivery products for back of eye diseases administered through implantation. In July they signed a tech agreement with an unidentified major biopharma for evaluation of Tethadur protein/antibody delivery technology.
        .......if I had to pick one to buy, I would probably pick the wrong one. That's why I buy a basket.
        Anyhow, thanks for ACTC....

    • Analyst, this is why I have been "strong buy long"!

      Sentiment: Strong Buy

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