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Keelan

Keelan
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  • InVivo Therapeutics Receives FDA Approval to Broaden Inclusion Criteria and Add 14 Additional Sites (20 Total) for Ongoing Pilot Trial [View article]
    This is sneakily enormously good news for NVIV.
    Oct 29, 2014. 10:35 AM | Likes Like |Link to Comment
  • Weighing The Pros And Cons Of InVivo Therapeutics [View article]
    Jason,

    Hey I know you're busy, but I was wondering where you discovered the IP issues that Invivo had? I've been trying to find them myself but as of yet haven't had any luck.

    Also do you have a timeline for when you expect to publish your follow-up article? I don't mean any offense when I say that this article served as more of a "soft-update". The factual information, regardless of how it's being presented here, doesn't seem to have grown anymore from your October article. Aside, that is, from the information included from the March 18th publication made by Invivo themselves.

    Again, I understand your need to get out in front of the new information as quickly as possible to maintain your integrity and credibility as an analyst covering this company and by no means am I insinuating that you jumped the gun here with an early publication (in fact, if I had to speculate, I think that the nature of this article... or at least it's effect on the PPS... gave management a ton of incentive to speak with you ASAP) but I am very curious to research the IP issues for myself.
    Apr 3, 2014. 04:19 AM | 1 Like Like |Link to Comment
  • Apple: Steve Jobs Was Right [View article]
    "... but the more important point is that sometimes myopically chasing only things that are obviously profitable today leads to tunnel vision. This, in turn, could doom the company's long-term prospects if the underlying markets change."

    Reminds me of something right out of "The Innovator's Dilemma". Very well written piece.
    Mar 3, 2014. 08:58 AM | 12 Likes Like |Link to Comment
  • Why An Uplisting Could Lead To A Surge In Demand For InVivo [View article]
    Very well written article. Maybe someone else can confirm but I was under the impression Zack's current PT is 6$.
    Apr 17, 2013. 04:15 PM | 1 Like Like |Link to Comment
  • Has Smith & Nephew Found Its Next Target? [View article]
    Thanks for clearing that up.
    Apr 4, 2013. 06:33 PM | Likes Like |Link to Comment
  • Has Smith & Nephew Found Its Next Target? [View article]
    I'm glad you've done more research RE: NVIV.

    Perhaps my estimate is a fantasy, I'm admittedly a long and perhaps that makes me marginally more biased. The IDE was submitted Feb 28th, and without a response in 30 days the IDE is auto-approved. Pending that approval (which, again-- I'm working under the assumption, biased or not, that it will be approved fairly soon), human trials begin. In primate studies efficacy became evident as early as 2 days and as late as 3 months ( ~7:30 of this video for the 'only scaffold' section: http://bit.ly/Ze1ytn). Of course, I apologize that I mistated the efficacy duration of 3 months-- my own DD yielded different information on a different video that I can't find now.

    Here are the facts that I'm considering in my reasoning; the FDA stated in their April meeting that the studies will be broken up into two 5-patient clinical trials, and primates showed efficacy between 2 days and 3 months. This data to me doesn't provide enough to make a true FORECAST of the timeline as primate studies are not symmetrical to human studies , but I'm PREDICTING 2-3 quarters (6-9 months), with additional time being needed for the FDA to process the information. You'd be correct in calling me optimistic, and as a long-investor, I certainly couldn't fault you if you called me biased... however only time will tell if my predictions are fantasy or reality.
    Apr 4, 2013. 02:38 PM | Likes Like |Link to Comment
  • Has Smith & Nephew Found Its Next Target? [View article]
    I mean if we're getting into the weeds of the species transition, technically there is a much larger gap between rats and monkeys (the study conducted prior to primates) than monkeys and humans. The author wrote 5+ years, but he also wrote that it was a drug and not a device-- I suppose both of these are true statements?

    I've read your posts a few times on the Yahoo board. I know your position and I know you don't like to support your assertions with data. I'm not saying there haven't been "negatives" worth considering with Invivo therapeutics-- if you want to make a case for Invivo being a risky buy the most informed way to do so would be to assert that their burn-rate won't sustain them long enough to see market. However, applying a moving-average of their burn rate to their current cash position puts them between 2 years and 18 months before they run dry (assuming no additional loans) so I'm still pretty confident.

    P.S. Try spelling running correctly, linking and quoting FDA regulations, and not tossing around ad hominem's... one tends to look more intelligent when they show restraint and poise.
    Apr 4, 2013. 01:12 PM | 5 Likes Like |Link to Comment
  • Has Smith & Nephew Found Its Next Target? [View article]
    D. Mero,

    "Early stage companies such as Invivo (NVIV.OB) and Verastem (VSTM) have market caps 8x and 10x greater than SNWV, respectively. To put into perspective, these budding companies are multiple years (5+) away from hitting market with their products, yet are valued at market caps 10 fold Sanuwave, a company with a potential product less than two years from market. Not to mention the countless risks involved in getting a drug to market from early phase I stages. Clearly, there remains a discounted imbalance with Sanuwave's valuation."

    I can't speak to Verastem as I don't follow it, but you're completely wrong about Invivo Therapeutics. First of all, it's not a drug-- it's a device. Second, It just received the Humanitarian Device Exemption and has a pending Investigatory Device Exemption that should receive approval within the next 2 weeks as the approval either comes automatically after 30 days (though the wording is unclear whether these are business days or calendar). The efficacy measurements are incredibly reduced relative to a non-HDE'd device, and the pre-market approval timetable is a much more rapidly moving process. This is a device that potentially demonstrates it's efficacy within 2 months (per primate studies), and thus market approval could come within the next 2 or 3 quarters.

    I'm sure the rest of your article holds merit, but confusing a medical device with a drug doesn't really help out your credibility.
    Apr 4, 2013. 11:12 AM | 4 Likes Like |Link to Comment
  • InVivo's Solution To Spinal Cord Injury Is A Billion Dollar Opportunity [View article]
    So in your mind an MBA misunderstanding the timetable for a Medical Device application is more relevant to a companies value than video's and heaps of quantitative data demonstrating the success of its product? That's an interesting perspective.
    Mar 14, 2013. 03:33 PM | Likes Like |Link to Comment
  • The Dendreon Bear Raid Of 2009: Chasing The Perpetrators [View article]
    In my limited experience, uncontrolled expectations / unrealistic timelines seems like the norm in the industry of small cap bio pharm rather than the exception.
    Mar 4, 2013. 09:22 AM | Likes Like |Link to Comment
  • The Dendreon Bear Raid Of 2009: Chasing The Perpetrators [View article]
    Very interesting read. I invested in DNDN Last year prior to its earnings beat that took it from ~7$ to ~13$ without ever knowing the story of Dendreon prior to its price collapse. I did about as much research as your average 22 year old investor and just assumed that this was a case of market catastrophe in the form of the reimbursable issue.

    Welp, looks like I still have a ways to go with my DD research skills.
    Mar 4, 2013. 09:02 AM | 1 Like Like |Link to Comment
  • InVivo Therapeutics: Why Run-Up To March 9 Likely [View article]
    My mistake, I went back to the FDA site (Here: http://1.usa.gov/15l2PNV )

    In the link above is the following, "An IDE application is considered approved 30 days after it has been received by FDA, unless FDA otherwise informs the sponsor prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved."

    My takeaway is that the IDE appears to run concurrent to the HUD submittal, and both are required before human studies can take place.

    -Keelan
    Feb 28, 2013. 10:01 AM | Likes Like |Link to Comment
  • InVivo Therapeutics: Why Run-Up To March 9 Likely [View article]
    This article was published today. (http://bit.ly/Y6BM5J). Based on the 45 day timeline, we could be looking at Approval in mid April. It's too bad the process has lasted this long and that the CEO has been somewhat misguided with his timetable since their meeting with the FDA last April (his forecasted FDA approval of Early 2013 which he issued after their meeting only makes sense if the updated IDE filing had already been submitted). On the bright side, InVivo's biopolymer scaffold appears to still fit the latest Humanitarian Use Device standards published by the FDA in January.

    -Keelan
    Feb 28, 2013. 07:39 AM | Likes Like |Link to Comment
  • InVivo Therapeutics: Why Run-Up To March 9 Likely [View article]
    Jason,

    In his latest presentation Frank Reynolds indicated that over the course of the HUD process the FDA suggested they change their manufacturing process from a 3D printing to some other process. This seems like the type of thing that would have reset the timetable. Nonetheless I think that the FDA making a designation of 2 five patient trials as opposed to a traditional 10 patient trial makes an FDA approval implied-in-fact, but that could just be bias.

    -Keelan
    Feb 15, 2013. 02:08 PM | Likes Like |Link to Comment
  • Look Out Below, Activision Blizzard: Finally A True WOW Killer [View article]
    Your thesis, which to me is more along the lines of "World of Warcraft is not going to be the industry leading MMORPG very soon" is slightly different than the thesis your title suggests, "HERE is a true WoW Killer".

    As for there being a 'WoW Killer'... I kind of disagree. I think it's fairly obvious that WoW has been passed its prime for some time. I dont know if in this current environment of F2P games such as League of Legends (Parent Company TCEHY), Guild Wars 2, KOTOR 2... etc. that there will be another game that generates as much solid perpetual income as World of Warcraft did for Blizzard (By the time of the Activision merger, WoW's best days were behind it). For one, I dont know that any other game will find such a large, dedicated, player base for so long (each of which paying a subscription fee). The games (and thus the companies that own them) must find more adaptive, creative ways to draw out income from their consumers without ruining the integrity of their games. In this F2P environment, each microtransaction of each game is in essense a new product with it's own potential failure and success. Because of this I have concluded that the market for companies which produce MMORPGs (or MMO's in general) is much more red than it has ever been before. There are greener pastures elsewhere.
    Sep 24, 2012. 03:12 PM | Likes Like |Link to Comment
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