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InVivo Therapeutics Holdings Corp. Message Board

factman777 8 posts  |  Last Activity: May 26, 2016 11:05 PM Member since: Oct 10, 2012
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  • Sorry, I could not attend the annual meeting this year. The JNAP interview and Richs375 answered many of my questions.

    As I had mentioned before, the company is going to approach the FDA about an expedited HDE once they reach the 5th patient conversion which could happen any day now with patient #7 having just reached the 2 month mark. With their outstanding working relationship they have developed with the FDA, it would not surprise me at all if they stop the INPSIRE trial and start the process of HDE approval. When I see some of these drugs that have been approved by the FDA with their long laundry list of side effects, it makes you wonder why something as safe as NSS will not be approved once the OPC is met.

    In my opinion, the company is executing just fine. They have condensed many timelines and clearly defined a solid business plan with plenty of cash going forward.

    So what is the problem? The SP below $7 is the problem. If the stock was over $15 there would be no problem. If I had attended the meeting the one question I would have raised was how I believe the company is simply not doing enough in getting the company story in front of more potential investors. (The WBZ radio interview is a good start but the PR should be before the interview takes place). When Frank was the CEO he was constantly going on the popular Business Shows and all he had to talk about was a bunch of monkey videos. The pilot trial had not even started and his promotion had the stock up to $24 pre-reverse split. Note: I am not advocating bringing Frank back. Now the company has made tremendous progress and has such a solid story to tell about how they are actually changing human lives and are well on their way of having the NSS become the Standard of Care for Acute Spinal Injuries.

    I urge all investors to contact the company about this issue. The company simply needs to do a much better job of getting their story in front of many more eyes.

    Just my opinion,
    -FactMan777

    Sentiment: Strong Buy

  • "Weekly Biotech Round-Up (May 20, 2016):

    COMING UP

    Next week I hope to publish my CEO interview with Mark Perrin of NVIV. That should really be a good one."

    Just the facts,
    -FactMan777

    Sentiment: Strong Buy

  • Jason Napodano's reply to my tweet about the Perrin interview...

    "Already did it, just waiting for them to review the transcript and get it back to me. Taking forever. Hopefully Monday or Tuesday."

    Just the facts,
    -FactMan777

    Sentiment: Strong Buy

  • From Jason Napodano's BioNap, Inc. dated today 5/6/2106:

    "Coming Up NEXT WEEK:
    Next week I have two CEO interviews planned. One with the Mark Perrin, CEO of InVivo Therapeutics (NASDAQ: NVIV) and another with Dror Ben-Asher, CEO of RedHill Biopharma (NASDAQ: RDHL). These are two of my favorite ideas right now and I'm really looking forward to sharing my conversation with both CEO's on my website next week.
    ________________________________________
    Thank you for reading my work. I'm happy to answer any questions!

    Jason Napodano, CFA"

    Just the Facts,
    FactMan777

    Sentiment: Strong Buy

  • From Mark Perrin:

    " We now only need one additional patient with an AIS conversion to meet the Objective Performance Criterion (OPC) "
    "We project our funds will last us through the end of 2017, by which time we expect to have filed a Humanitarian Device Exemption (HDE) application for approval of the Neuro-Spinal Scaffold™.”

    My understanding is that once the next patient converts they are going to approach the FDA for early approval. Remember they have built an excellent relationship with the FDA.

    Also, the company should soon initiate a study for cervical spinal cord injuries, If the NSS works in the mid to lower spine it certainly will work in the upper spine (cervical). And the benefits from the NSS implanted in the cervical region of the spine will be exponentially greater.

    Just my opinion,
    -FactMan777

    Sentiment: Strong Buy

  • Reply to

    Patient #7 - 30 day eval

    by onemill2go Apr 29, 2016 9:56 AM
    factman777 factman777 Apr 29, 2016 11:10 AM Flag

    Patients are evaluated at 1, 2, 3, and 6 months.

    Patient #6 converted at the 2 month evaluation.

    Just the facts,
    -FactMan777

    Sentiment: Strong Buy

  • factman777 by factman777 Apr 26, 2016 9:39 AM Flag

    "$NVIV OPC for INSPIRE trial was 25% of n=20 improve. That’s 5 patients. They are at 4 of 7 right now!! I think they file early."

    "This is great news for $NVIV. They are at 4 of 7 patients improved so far, with 1 patient will under review."

    Just the facts,
    -FactMan777

    Sentiment: Strong Buy

  • Reply to

    Patients

    by vincent_vivo Apr 8, 2016 11:12 AM
    factman777 factman777 Apr 8, 2016 1:20 PM Flag

    I believe that once we have 5 patients that convert on the AIS scale InVivo will approach the FDA and try to end the study early since they will already have reached the 5/20=25% requirement.

    Remember that InVivo has a great working relationship with the FDA and several times in the past they have reduced their timelines such as:

    - concurrent enrollment of patients 3-5
    - rolling the pilot study into the pivotal study where the 5 patients in the pilot are counted in the pivotal

    Just my opinion,
    -FactMan777

    Sentiment: Strong Buy

NVIV
5.54-0.52(-8.58%)Jun 27 4:00 PMEDT