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InVivo Therapeutics Holdings Corp. Message Board

factman777 15 posts  |  Last Activity: Feb 4, 2016 2:34 AM Member since: Oct 10, 2012
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  • Reply to

    Is there anyone here who isn't a basher?

    by sirchampalot Feb 3, 2016 7:23 PM
    factman777 factman777 Feb 4, 2016 2:34 AM Flag

    I am long term investor who still believes in the science. Wished I had sold when we were $17.00. but I sure management wished they had done a secondary when the stock was at $17. Management has done a good job of rolling the pilot into the pivotal study. We are at $4 because of the following:

    - the market and especially the bio-techs have crashed.
    - it is now 5 months since patient #5 was enrolled. I believe rolling the pilot into the pivotal and some minor changes in the enrollment protocol delayed the enrollment. Patient #4 and #5 were enrolled a month apart with 13 sites enrolling.

    Like one poster mentioned. It is now all about enrollment. With 15 sites currently enrolling, patient #6 could occur at anytime. This should cause the stock price to reverse the downward trend.

    Best time to buy a stock is when it is out of favor but still has a promising plan going forward. All we need is an enrollment and some more patience.

    Just the facts,

    Sentiment: Strong Buy

  • Dec 3 continued: “The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury.” The INSPIRE Study is designed to enroll 20 implanted patients, inclusive of the five patients already enrolled.
    The FDA has also agreed to increase the total number of allowable U.S. sites to 40. In addition to the U.S. sites, the company plans to initiate the study in Canada and the United Kingdom with the intent to include patients enrolled at ex-U.S. sites as part of the 20 patient study.
    Dec 17 - CEO Perrin posts CEO’s Perspective on: InVivo in 2016: Looking Ahead. CEO stated: “It is extraordinary to think that just over a year after enrolling the first patient in our study, we are now running a pivotal trial with planned international expansion and the potential to file an application for HDE approval in just two years."

    FactMan777: please see:
    to read the full CEO Perspective : InVivo in 2016: Looking Ahead

    Obviously, InVivo has accomplished a lot during the year 2015 (even though the current share price of $7.20 doesn't reflect this).

    Looking forward to year 2016. I am betting the share price will increase and start to reflect the company’s many accomplishments. InVivo is well on their way to providing the standard of care for spinal cord injury (SCI) patients.

    Just the facts,

    Sentiment: Strong Buy

  • Oct 19 - InVivo announces that the U.S. Food and Drug Administration (FDA) has approved the expansion of the number of patients from five to ten in the company’s pilot study of its investigational Neuro-Spinal Scaffold™ implant in patients with acute thoracic spinal cord injury.
    Oct 23 - InVivo reports Significant Improvement of First Patient Implanted with Neuro-Spinal Scaffold. In the time between the 6-month and 12-month post-injury assessments, the patient continued to demonstrate improvement in the American Spinal Injury Association (ASIA) lower extremity motor score with an additional 8 points gained on this 50 point score. The patient demonstrated additional bilateral improvements in the motor function of hip flexors and knee extensors and for the first time bilateral contractions of the ankle dorsiflexors and ankle plantar flexors. A large natural history database shows that patients with similar level injuries (T10-T12) have an average increase of lower extremity motor scores between 6 and 12 months of fewer than 2 points.
    Dec 2 - InVivo announces - an innovative strategy for the treatment of chronic spinal cord injury (SCI). The company will focus its research efforts for chronic SCI on Bioengineered Neural Trails™. Bioengineered Neural Trails are injectable combinations of biomaterials and neural stem cells (NSCs) delivered using minimally-invasive surgical instrumentation and techniques to create trails across the chronic injury site.
    Dec 3 - InVivo announces it has received conditional approval of a study protocol amendment from the U.S. Food and Drug Administration (FDA) that will convert its ongoing pilot study into a pivotal probable benefit study. The approval is conditional solely upon a minor change to the informed consent form that has already been submitted to the FDA. Full approval of the amendment is expected in the next 30 days. With this transition, the study will be known formally as “The INSPIRE Study:

    Sentiment: Strong Buy

  • Jun 29 – InVivo makes it official and announces that the company has been added to the Russell Global, Russell 3000®, Russell 2000®, and Russell Microcap® Indexes on June 26, 2015.
    Jun 30 – InVivo announces that Rutgers New Jersey Medical School in Newark, NJ has been added as the 12th clinical site.
    Jul 6 – InVivo Reports Significant Improvement of second and third patients Implanted with Neuro-Spinal Scaffold. The second patient demonstrated marked improvement in sensory function with partial sensation present five dermatome levels lower on the right side compared to the three-month assessment. In the time between implantation and the one-month post-injury assessment of the third study patient, the patient improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury.
    Aug 12 - InVivo announces the Cooper Neurological Institute (CNI) in Camden, NJ has been added as the 13th clinical site in the company’s ongoing IDE pilot study
    Aug 20 – InVivo announces that a fourth patient has been enrolled in the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute thoracic spinal cord injury at the UC Davis Medical Center in Sacramento, CA.
    Aug 24 - InVivo announces that the listing of the company’s common stock has been transferred to the Nasdaq Global Market. The company’s common stock previously traded on the Nasdaq Capital Market CEO Perrin stated: “:Being listed on the Global Market allows us to be considered for a broader array of indexes, including the NASDAQ Biotechnology Index.”
    Sep 8 – InVivo announces that a fifth patient has been enrolled in the company’s ongoing pilot study of its investigational Neuro-Spinal Scaffold™ implant in patients with acute thoracic spinal cord injury at the Keck Hospital of University of Southern California (USC) in Los Angeles.
    Sep 9 - InVivo announces that Mount Sinai Hospital in New York has been added as the 14th clinical site.

    Sentiment: Strong Buy

  • Mar 30 - InVivo announces that the University of Kansas Medical Center in Kansas City, KS has been added as the 9th clinical site.
    Apr 1 – InVivo announces the UC Davis Medical Center in Sacramento, CA has been added as the 10th clinical site
    Apr 8 - InVivo announces the implementation of its previously disclosed 1-for-4 reverse stock split as of today, April 8, 2015, a key step in preparation for its planned uplisting to the NASDAQ Capital Market.
    Apr 16 - InVivo today announced that its common stock has been approved to begin trading on The Nasdaq Capital Market. The company’s common stock will begin trading on Friday, April 17, 2015
    May 19 – InVivo announces the Goodman Campbell Brain and Spine in Indianapolis, IN has been added as the 11th clinical site.
    Jun 1 – InVivo announces the company’s investigational Neuro-Spinal Scaffold has received the 2015 Becker’s Healthcare Spine Device Award. It is one of 25 devices that received this distinction from Becker’s Healthcare.
    Jun 5 – InVivo’s announces that a third patient has been enrolled in the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury at the Carolinas Medical Center, part of the Carolinas HealthCare System in Charlotte, NC. Dr. Coric, who enrolled the 2nd patient (Jesi Stracham) also performed this Neuro-Spinal Scaffold implantation
    Jun 12 – InVivo makes the preliminary list to be added to the Russell 3000, Russell Global and Russell Micro Cap.
    Jun 15 – InVivo announces that James Guest, M.D., Ph.D., has joined its Scientific Advisory Board. Dr. Guest is currently a Professor of Neurological Surgery at the Miller School of Medicine and the Miami Project to Cure Paralysis in Miami, FL
    Jun 16 – InVivo holds annual meeting. InVivo stated: Expedited Access Pathway (EAP) may be an option for devices to treat SCI.

    Sentiment: Strong Buy

  • Jan 9 - InVivo announces the reopening of subject enrollment for the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury. To date, there have been no reported serious safety events with the study’s first subject.
    Jan 21 - InVivo reports three-Month Update of First Acute Spinal Cord Injury Subject Implanted with Neuro-Spinal Scaffold - Motor, Sensory, Bowel, and Bladder Function Improvement with No Reported Serious Adverse Events.
    Jan 22 - InVivo announces Enrollment of Second Subject in Pilot Spinal Cord Injury Trial.
    Feb 5 - InVivo announces the appointment of Mark D. Perrin as Chairman of InVivo’s Board of Directors, effective immediately.
    Feb 9 - InVivo today announced the appointment of Lorianne Masuoka, MD, as Chief Medical Officer (CMO), effective March 2, 2015. Prior to joining the InVivo team, Dr. Masuoka served as Senior VP and CMO at Cubist Pharmaceuticals from July 2013 until Jan 2015. Merck acquired Cubist in January for $102 a share ($9.5 billion buyout).
    Feb 23 - Froedtert & the Medical College of Wisconsin (MCW) Froedtert Hospital in Milwaukee, WI has been added as the 7th clinical site in the company’s acute SCI pilot study.
    Mar 11 - InVivo provides update on patient #1: In the months that followed, an appreciable improvement in the first subject’s motor and sensory function was reported (improved from AIS A to C) as well as complete recovery of bowel function and improvement in bladder function.
    Mar 23 - Video of Jesi moving her leg posted on the “Jesi S - NVIV Investor's Give gofundme” website
    Mar 24 - InVivo announces 1-for-4 reverse stock split in preparation for planned uplisting to NASDAQ.
    Mar 25 - the Keck Hospital of University of Southern California (USC) in Los Angeles, CA has been added as the 8th clinical site
    Mar 26 - InVivo announces the reopening of concurrent enrollment of subjects 3, 4 and 5 in the company’s acute SCI pilot study.

    Sentiment: Strong Buy

  • factman777 by factman777 Jan 1, 2016 5:46 PM Flag

    Here's wishing a Happy, Healthy and Prosperous 2016 to all posters on this message board,

    We are so much closer to the payoff now (with the SP= $7.20) than when Frank was pumping the stock (SP= $24) and the company only had some monkey videos to show and had not even started the now completed Pilot study. A ton of good stuff has happened since then.

    Looking forward to a solid 2016 as management continues to execute.

    Just the facts,

    Sentiment: Strong Buy

  • factman777 by factman777 Dec 18, 2015 3:00 AM Flag

    Bio-tech Company Roles

    Bio-tech Company Roles:

    - build a solid leadership team.
    - have a solid Scientific Advisory Board behind the company. Note: Bob Langer is 2nd to none.
    - develop a product for an unmet medical need.
    - if possible, develop a product that has minimal or no competition.
    - prove the product is safe.
    - prove the product is effective.
    - set a clear path for commercialization within reasonable time frames.
    - set investor expectations accordingly.
    - keep at least a year of cash on hand.
    - keep debt to an absolute minimum.
    - expand internationally.
    - continue R&D on new products.
    - develop and maintain a strong working relationship with the FDA. This is SOOOO important.
    - if possible, condense time frames while working with the FDA.

    Investor Roles:

    -determine if company is executing their roles. If so, continue to hold long position and add on dips. If not, then determine if the company is at fault or is it something out of the company’s control like an FDA delayed response. If the company is not at fault then continue to hold and add on dips. If company is at fault then sell and move on.
    -while holding long positions, investors need to exercise patience while management continues to execute on their plan.

    Trader Roles:

    -try to determine the timing of buying a dip or selling a rally
    -don’t cry on the company’s message board that the company is not executing when you didn’t guess right and were out manipulated by the stock manipulators and now have a short term loss.
    -consider becoming an investor and playing online poker or visiting casinos on weekends to relieve your gambling urges.

    Clearly, Invivo is playing their roles and executing flawlessly.

    Just the facts,

    Sentiment: Strong Buy

  • Reply to

    New CEO Perspectice released at 11:08 am EST

    by factman777 Dec 17, 2015 11:26 AM
    factman777 factman777 Dec 17, 2015 11:56 AM Flag

    After the Frank debacle and the unbelievable manipulation going on in the bio-tech world, it is always prudent to set very realistic goals so over-delivering is a strong possibility. Do not under estimate the strong relationship the company has built with the FDA. Ultra important for a small bio-tech company.

    Just the facts,

    Sentiment: Strong Buy

  • Check it out:

    Good stuff.

    Management continues to execute.

    Just the facts,

    Sentiment: Strong Buy

  • factman777 by factman777 Nov 29, 2015 3:20 AM Flag

    Question and response from another board about the recent hiring of Jay Blackington as New Vice President, Head of Human Resources.

    "Why have they just hired someone who managed 5000 people to be their VP of human resources?"

    "Must be about their future plans; they have to get the manager before the the employees. Are they about to go after the acute international market? Are they about to move into the chronic market in earnest? I would say it indicates growth is planned for the future! A couple standout points in the PR for me were:".... most recently provided the HR leadership in establishing eight new global delivery Centers of Excellence located in India, China, Russia, Israel, Egypt, Ireland and the USA. Prior to that, Mr. Blackington held human resources leadership positions, located both in the USA and in Asia Pacific, at industry-leading global enterprises including State Street, Monsanto, First Data, and Honeywell." And: ... " His wealth of knowledge and ability to effectively attract, develop and maximize human capital will make him a valuable asset as we progress into the pivotal probable benefit study, commercialization, and beyond," said Mark Perrin, InVivo's Chief Executive Officer and Chairman.
    THIS MOVE IS ALL ABOUT GROWTH. IMO significant plans about what the future holds may be revealed Dec 3rd!"

    Just the facts,

    Sentiment: Strong Buy

  • Fourth, insurance and national health insurance reimbursement is assured. NO STUFF LIKE, THE INSURANCE INDUSTRY WILL NOT REIMBURSE YOU.....The numbers are so utterly overwhelming, the fact is that every insurance company and health care system will beg to reimburse our solution.

    Fifth, THE SHORTS ARE LARGELY DEFANGED. yes they will lie, cheat and steal and lie and defame and slander some more, but what are they going to say? Look at the utube footage, before and after? They can talk and lie on Seeking Alpha all they want but we have the footage. What are they going to say, the monkeys were a hoax, that the footage of human patients is rigged, an internet scam rig type of thing? PALEEEZE.

    The Wall Street shorts have their power from many sources, but their primary tool is the written or typed word. What are they going to do when there is video proof? Is it all faked? ha ha ha? These human #$%$ are defanged. Let them try, the wall street elephants will trample them underfoot.

    Sixth, SOON BABY SOON.........WE DO NOT HAVE TO WAIT 3 OR 4 OR 5 OR 6 OR 7 OR 8 YEARS, LIKE CANCER BREAKTHROUGH DRUGS, with endless dilutions and more dilutions on top of dilutions. NVIV IS ALL CASHED UP....our patients know if the cast works in about a month, and from there, they keep getting better and more better.

    Seventh: top tier science people from our company. Look at Dr. Langer's credentials. He was and is and has been the CZAR of the FDA. WE are MIT rich with people. We are located in the epicenter of biotechnology, Cambridge, Mass. Top of the Tier Pedigrees

    Conclusion: We are the only game in town, on the planet, and there is no competition.
    NVIV, the perfect technology, multi-billion dollar markets, the perfect investment.

    Just the Facts,

    Sentiment: Strong Buy

  • Good post to recall from tootalljones

    I am not Rasputin the Mad Russian Monk but I have been at this for 30 years, trading and owning and swing trading, but never day trading. This is the single best investing opp in my entire life. Why?

    1st and foremost, NO COMPETITION. It is hard to underestimate how important that is. In every single area, or almost every one, there are 3 or more companies competing for the prize, and in some areas, like Psoriasis, for instance, and this inflammatory condition is complex and varied, there are literally almost 2 dozen Big Pharma (BP) and brilliant smaller bio-techs fighting for the potential that is there.

    If I am a little biotech, with a great psoriasis solution, and a great technology, I must fight against two dozen BP companies, who have jobs at stake, and their own P drug in the works, and they may lie, cheat or misrepresent along the way, and they will outlast you and your visionary shareholders. Make no mistake, money is money, and where jobs and families are at stake, BP will screw the daylights out of the little guys, if they have a competitive product in development. FactMan comment: this could also apply to AVXL with their AD drug.

    2nd: billion dollar markets, in North American and worldwide. I will elaborate later. Actual multi-billion dollar markets, and a 25 billion dollar worldwide CHRONIC MARKET, that is simply waiting there, begging us to come and help all these unfortunate people. Nobody is trying to help them, not corrupt big BP, not little companies, not anybody as there is no help, and no standard of care.

    3rd, speed of approval. Speed of Approval. We are highly visible and guess what, think of our brilliant product like a cast or a splint, or a ...SCAFFOLD !!! NO #$%$ DRUGS, NO BIOLOGICS, NO STUFF LIKE: DOES IT BUILD UP IN YOUR SYSTEM?, NO STUFF LIKE: WILL IT WEAR OFF OVER TIME?

    Sentiment: Strong Buy

  • factman777 by factman777 Nov 19, 2015 5:50 PM Flag

    Nothing has changed fundamentally with the company except:

    - biotech in general have corrected the last 6 months
    - Clinical timelines have been compressed by rolling the Pilot study into the Pivotal study .
    - Additional patients may receive the Neuro-Spinal Scaffold under the Emergency Use Expanded Access Mechanism while the Pivotal study terms are discussed with the FDA.

    I expect we should be hearing about the following by year end.
    - Update on Patient #4
    - Update on Patient #5
    - Finalization from the FDA about the Pivotal Probable Benefit Study which should include the study design and updated associated time lines. Since their relationship with the FDA has been nothing short of extraordinary I would expect a favorable study design.
    - Enrollment of next patient(s)
    - Additional Clinical Sites coming on board.
    -The number of clinical sites expanded to greater than 20.

    My understanding is that the company is carefully evaluating how they are going to approach the chronic market using stem cells. They are evaluating if they want to go with the Hydrogel / stem cell approach (less invasive) or apply the NSS with stem cells (more invasive).

    All biotech companies require a little patience. I believe when all is said and done, InVivo will provide the new standard of care for the acute and chronic injury. It is just not going to happen overnight.

    Just the facts,

    Sentiment: Strong Buy

  • Reply to

    Capital surplus + Cash

    by aretxen Nov 11, 2015 2:45 PM
    factman777 factman777 Nov 11, 2015 3:11 PM Flag

    The ATM would never be executed with a 50K trade that immediately drops the stock 50 cents. If the ATM is being used it would be difficult to determine that from trading patterns. There are algorithms used so the ATM has minimal affect on the stock price.

    Just the facts,

    Sentiment: Strong Buy

4.02-0.21(-4.96%)Feb 5 4:00 PMEST