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Talked to IR just now (Brian Luque). Brian used to work on the research side of the company before becoming director of IR. He said he is well connected to what is going on inside the company.
I told him that I would be concerned how the market would read this news as being related to a "medical condition" and needed some assurance that there were not underlying issues related to the plans to begin testing their scaffold product this fall in hospitals, whether that could be related to hospitals agreeing to perform the procedure, insurance issues, or other issues related to the viability and acceptance of this product. Brian assured me that nothing has changed with regards to plans to use the biopolymer scaffold in patients this fall.
I also told Brian I would be concerned that the market might read the signals wrong as if the head of company is jumping ship due to something that troubles the company, like a rat fleeing a sinking ship. Brian assured me again that nothing has changed, that the company still plans to uplist. I asked Brian if this change (appointment of interim CEO and a CFO) would now mean that all the requirements of corporate governance that had to be taken care of had now been achieved on behalf of what was required of InVivo. Brian said that the company's PR news releases stated corporate governance issues were the reason for the uplist delay and that nothing has changed in that the company still plans on uplisting.
Lastly, I asked Brian if there were any other things to be concerned with as a personal investor who might have a large position in the company, that whatever the market reaction may be, whether the company would recover from such market reactions if their milestones could be met for fall 2013 for start of patient trials and for hydrogel submission to FDA. Brian stated that they were still moving ahead with everything as they have announced and that the CEO/CFO change was not affecting any of that. He said it is possible when the interim CEO contract period is up in January 2014, there is a possibility they might make him an offer to stay on permanently.
I am just cross-posting what I read on Yahoo and helping the free flow of information. Jason Napodano, the Zacks analyst who is following and rating this stock, got basically the same information when he talked with them about 3 weeks ago.
In the scheme of things, NVIV has achieved what they set out to achieve for several really key milestones -- HUD approval and IDE approval way back in April, and calling in warrants successfully which set them up for the proper capital structure to uplist.
I am personally not trading this stock just on the exact date of either the uplist or the start of clinical implants of the biopolymer scaffold. Since they have a first rate team on board including spinal surgeons and other top doctors in the field, I have no doubts in my mind that the hospitals they are working with will allow trials to proceed.
Lastly, missing an uplist projection date is almost the rule rather than the exception with most stocks. You can read on NASDAQ and NYSE that the timeframe to uplist can occur within 6 to 8 weeks, but in the real world things don't happen that fast, you can cite dozens of stocks where 3 to 6 months was the norm from when they first announced their intentions. Furthermore, it is a very common scenario that minor changes to a BOD or other corporate modifications are stipulated by the Exchange as corrective action before a company is approved to uplist.
In conclusion, there is no reason to be distrustful that these things won't happen, nor is there a reason to doubt whether the company is making progress and anticipating they will happen at the dates indicated. As always, you can never time the events in virtually ANY biotech, and with NVIV at least we are not looking at predicting a binary outcome of an FDA approval or disapproval in the next 6 months, since the scaffold is regulated as a device and not a drug.
Heads-up. Sale price here, IMO management and larger holders want this to maintain $4 PPS closing price to maintain NASDAQ uplisting eligibility, so the closer you can grab shares to $4, you are doing pretty good. There has been very high volume buying every single time this has tried to go a couple of pennies below $4, so that appears to be the case.
All out 1.25 to 1.26. Negative media is controlling sentiment right now and I don't want to get trapped underwater for the time being. Still on watch list.
IL Padrino, I also agree. Stay focused on trading strategies, it's what this board is meant for.
This post was off-topic and normally I would not reply to any political discussion on I-hub. However, that being said, I want to emphasize that FNMA is closely tied to that portion of administration policy related to affordable housing, and throughout the 2008-2009 financial crisis very aggressive steps were taken to maintain liquidity of lending, to prevent banks from failing and catapulting the US into a run on the banks just as in 1929. And the maintenance of low interest rates has had a HUGE influence on helping stimulate the economic recovery. And stimulus also helped the stock market to recover, which in turn helps small companies to raise capital needed for growth and helps private citizens to restore lost personal wealth and then turn around and invest or spend that wealth in the economy.
Here is what I feel is a list of 1.5 term accomplishments, FWIW:
1) Healthcare Reform
2) Ending Iraq War
3) Killing Osama Bin Ladin plus his highest ranking deputies
4) Passing Dodd Frank and consumer credit card reform
5) Deftly handling a return from the precipice after the worst recession since 1929, including maintaining bank solvency, real estate lending liquidity, low interest rate economic stimulation, recovery in jobs, and helping Americans to avoid foreclosure
Now that would be a fair accomplishment for any president, however, in Obama's case he is up against a recalcitrant party who has publically stated their primary intention is to make every single Obama initiative fail at all costs to the United States of America. Without that backdrop, Obama could have easily passed budgets, downsized the military, created new infrastructure jobs, and strengthened Dodd Frank with more teeth in the bill.
InVivo has indicated in their latest corporate presentation (dated 7/30/2013) that the scaffold clinical study would begin "early fall 2013" and that results would be available in 2013, but the FDA would not have a final report until 2014. Since the scaffold healing takes around 2 months to become evident after surgery, this means that trials would have to approved by around mid-September and surgeries performed that same month or at least by early October in order that preliminary findings could be analyzed before the end of the year.
InVivo's corporate presentation also indicated that the peripheral nerve pain hydrogel FDA submission is planned for "Q3 2013", which could be anytime before the end of September.
From Yahoo Board, Investor Relations update:
Update...
Just got off the phone with Brian Luque. I asked 3 questions, which I had referred to in an email last week.
Q: Investors have been concerned about the wording "indefinite" in the 8K that announced uplisting would be delayed. Does that mean that the uplisting has been "canceled" or is InVivo taking steps to perform the necessary changes in corporate governance cited in their news release about uplisting?
A: InVivo did not mean that the uplisting was canceled, just that they had to take steps before uplisting and they didn't know the exact time this would require. Brian said he was actually quite upset that the lawyers had made them use the wording, "indefinite". But he emphasized that they have already taken steps and are still engaged in the process of preparing to uplist. However, he noted they cannot issue a PR just yet about uplisting schedule.
Q: InVivo has stated that the biopolymer scaffold patient implants are estimated to begin early fall, with meetings involving hospital Institutional Review Boards (IRBs) necessary before they can begin trials. Does InVivo believe patient implants will be on-track for early fall?
A: InVivo anticipates the IRB approvals will enable patient implants to begin in early fall for the biopolymer scaffold.
Q: InVivo has stated that their application to FDA for methyl prednisolone hydrogel would be on a separate track expected for submission in early fall. Is this schedule still anticipated to be met?
A: Yes, InVivo anticipates FDA submission to occur within their projected timeframe.
At this time, the scaffold is designed only to help acute injury victims within the magic window of 2 or 3 days after injury before damage to nerves and progression to eventual scarring begins. This is stated in several video presentations and is the concept behind why the scaffold will serve as a barrier during the period when stem cells would be attacked by the body's own reaction to injury. So far, no one has proposed a way to insert the scaffold into an already scarred region, although conceivably it might involve removal of an additional section of spinal tissue at the terminal ends of the injured region prior to treatment. Baby steps, have to prove benefits with the acute injury population first.
It was just grandstanding to selectively excerpt certain rhetoric from a speech made a couple weeks ago. No "report" with that title was just released. Could've guessed based on history, LOL
It already did provoke a mini-spike on Friday, which went from $1.23 to $1.47, then faded at the end of the day to $1.36, just typical late-afternoon Friday behavior. The bigger picture is that Berkowitz already owns a large stake (7 million shares) and plans to buy much more. He will have done much better due diligence than all of these message boards combined could ever do. So a follow-the-leader-move is quite likely to continue.
The mission name: Operation Darwin
As a mod, I can't comment on things like bashers because it falls within the category of making personal judgements of posters or their perceived integrity, which are technically off limits per TOS. Likewise, there are limits to posting "going to the moon" or "gonna get flushed", without providing substance to support these beliefs, either. GLTA.
What IS relevant here is amazing potential with NVIV's near-term catalysts that represent an opportunity to revolutionize treatment and a cure for acute-injury induced spinal paralysis, post-injury inflammatory damage and scarring, and spinal pain management. There are zero therapies with approval to address no. 1 and no. 2 at this time.
Also, note the certainty in the following catalysts - the following events are not binary, might, maybe, or possibly types of events, as hurdles have been overcome and merely events need to be set in motion now:
(1) the FDA has approved a 5-patient trial of the biopolymer scaffold implant, no ifs, ands, or buts. Three hospitals have agreed to conduct these implants. All that remains is for their institutional review boards to agree on details, and typically these IRBs are composed of proactive doctors and management, who just want to make sure protocol is followed, patients have informed consent, appropriate waivers and insurance, and only the most qualified doctors perform the procedures and ensure followup care is also done with the best professional monitoring. The mere announcement of trials startup will send shockwaves through the medical community as this is a first of its kind event, an opportunity to potentially change the life of a paralyzed person or persons.
(2) Submission of the FDA application for methyl prednisolone hydrogel is scheduled for early fall. This is a formality and by itself not a difficult or exhaustive effort. NVIV has been planning this for a while. Once it is submitted, analysts who had been holding off on factoring in the future valuation of this product will have tangible details to rewrite their target price projections, which until now had not taken hydrogel into account. This is a $2 billion USA market and well over $5 billion worldwide market, which for a smallcap like NVIV represents an explosive growth opportunity. Announcement of a partner once that product is approved could foresably support a valuation in the $20+ range, according to several preliminary projections.
Personally, I get a lot more useful information from discussing the biotech product line of this company, and their financial projections and current financial health status, than market sentiment and subjective opinions of the CEO, his personal life, his weight, or his marital status. And just to set the record straight, despite a temporary postponement of uplisting (you can't argue that the definition of postponement is itself a delay not a cancellation), I haven't noticed a deterioration of average sentiment...a recent survey showed 41 posters held versus only a couple said they sold during the quick dip to $3.92 a week ago when an 8k announced postponement because corporate governance issues had to be resolved prior to approval for uplisting.
Technicals show this stock was above $4 merely on trials starting not on uplisting, and the chart showed 180,000 shares - over $800,000 - were instantly gobbled up and bought when the stock beached $4 for only 15 minutes. The 50 DMA remains solid.
In summary, the catalysts are the reason folks are accumulating, as there is likely to be a profound impact on medicine introducing the scaffold alone or with hNSCs to cure paralysis. Uplisting is now priced in as "postponed" in terms of sentiment. Given volume is always very low during the August -referred to as "the dog days of summer" - many are hoping for a bargain and watching this closely for dips. GLTA. Other issues - corporate governance in particular, are nothing but growing pains and one of the most common easily surmounted problems that the Exchanges most often require fixing among an uplisting company.
Contrarian theory of gold prices ... serious comments welcome:
Since gold has been tied to an inflation hedge, the more likely inflation is projected to occur, the more likely gold goes upwards. Therfore, the more evidence we see of inflation happening, the more gold will tend to spike upwards.
Since QE won't be eliminated until the economy is firing on all or nearly all cylinders, therefore, the end of QE will be correlated with higher economic output. In turn, higher economic output will trigger higher oil and commodity prices, which then trigger an increase in inflation to a measurable, but not necessarily runaway crazy extent. A marked increase in inflation will trigger gold to rise.
So the theory that the end of QE will cause a large drop in gold prices over the following months is opposite to what will happen. Sure, there could be a knee jerk reaction around the actual announcement date of QE ending, but the underlying factors will persist over the 4 to 6 month period after that point in time, which leads to an increase, not a decrease, in the price of gold.
Totally agree...NVIV doesn't want to make the same mistake twice:
"If they gave an estimated date,
they would be held to the fire.
Easier to say postponed indefinitely,
especially, if you do not have a definitive
time frame."
After rerating neutral, Napodano writes bullish article:
http://t.co/yZVNRfCgc9
Frequently corporate governance issues in uplisting involve the independence of the board of directors or another issue regarding management structure. No way to know based on filing at this point, but if I had to guess, I'd say maybe they might have to appoint new folks to certain positions. That type of hangup can set them back a month or so. But it's only a guess.
Exactly...big moves mean big volatility.
Step back and look at the year-to-date, chart is a beautiful thing.
The 50-day moving average shows there is no question at all about where this is headed. Biotechs as a rule have huge standard deviations, which for NVIV means a 75 cent to 1 dollar fall after each move upwards by $1.50. You can time it if you are an expert, but I'd rather just stay in for the big haul.
On NYSE, must have at least 3 independent BOD. You can have more than that and the remaining ones don't have to be independent. I know this because another stock I was in that uplisted to NYSE had to add a third independent member to their BOD in order to uplist. Don't know if NASDAQ is similar. (Right now we don't know - and NVIV doesn't know - which one will let them uplist first, as they've been working with both NYSE and NASDAQ uplisting applications.)
Latest update on uplisting progress NVIV:
from a yahoo poster this morning ("Slurppy123"):
"We are diligently working with both exchanges every day to get us up listed. You’re correct with regards to the process and ,unfortunately, I can’t give any more detail beyond that at this point. No material delays as far as I’m aware.
As soon as I can give a date, I’ll issue a press release."
Best,
Brian Luque, Investor Relations &
Business Development Manager
InVivo Therapeutics Corporation
Yahoo poster got update from IR today:
Slurppy123 said he got this response from Brian Luque of NVIV IR regarding progress towards uplisting:
"We are diligently working with both exchanges every day to get us up listed. You’re correct with regards to the process and ,unfortunately, I can’t give any more detail beyond that at this point. No material delays as far as I’m aware.
As soon as I can give a date, I’ll issue a press release."
Best,
Brian Luque, Investor Relations &
Business Development Manager
InVivo Therapeutics Corporation
Jason neglected hydrogel in his NVIV price target. See his PropThink article on NVIV in SeekingAlpha, in which he states that he had projected a $5 price target based on the biopolymer scaffold implant by and of itself. Kind of funny to see a Zacks analyst intentionally leave out the valuation attributable to a second key pipeline drug - methyl prednisolone hydrogel time release injectable formulation. Especially when the hydrogel has an orders of magnitude larger revenue potential and submission to FDA is planned for this fall. IMHO, the hydrogel represents a high probability of success because prednisolone is already approved by itself for use, it is only the time-release biogel matrix formulation that makes it unique. Oh well, this gives Jason an excuse for being low with his recent price target on NVIV, and then leaves him wiggle room to do a whole new valuation assessment and analyst recommendation when the FDA submission occurs later this year. He's thinking like an analyst, not like an investor.
Uplisting anytime: Don't daytrade or you could miss it and have to chase.
Heading north on 4 catalysts to $10, then $15, then $20-$25, then blue sky on positive trial results
Each of the 4 upcoming massive catalyst events has tremendous potential. Uplisting by itself should bring a one week run to about double the current price. Institutions want into this stock as soon as it uplists, which is a very strong catalyst for this magnitude of uplisting pop, regardless of any pre-uplisting move.
After uplisting there could be a rapid 1-2-3-punch of additional catalysts, or these catalysts might be separated ranging from 3 weeks to 3 months apart, which impacts the effects on the chart of slight post-catalyst fades which typically occur 2 weeks after any catalyst event.
Bigger investors see the medium-term and longer-term value still to be unlocked as NVIV reaches future milestones, and this alone will drive a steady stream of buying pressure for months after the uplisting. Even with a 2-month delay between uplisting and start of patient trials, this just means institutions will be accumulating more shares before the next event. The fades after each event should be only about $1 per share pullback, based on that reasoning.
A likely scenario is roughly a move from $5 to $10 upon uplisting, then a $1 to $1.50 pullback two weeks later. Institutions will accumulate while the stock bases at a PPS of $8.50 to $9 until the market believes announcement of patient trials is imminent. NVIV has had their ducks in a row since the warrant redemption deadline expired in the beginning of June. Two months from that point is all it takes under nearly any circumstances, or maybe 3 months tops if it requires another director or 2 on the board to meet independent oversight requirements, but I doubt it.
Upon announcement of startup of patient trials, we move from about $9 to $15, then pullback to $13 or $14. Hydrogel submission should take it to $20-$25, then a pullback to $16 to $18 until preliminary outcome news of patient trials is announced. At that point good news could take NVIV to $30 or $40 PPS.
$LSTMF: Target +50% upside off YTD chart lows ($11), WITHOUT Keystone approval. Keystone approval catalyst for 100% upside ($15 target).
$NVIV: CEO's 60-day uplisting window prediction falls within next 10 days. Be there or be square!
$NVIV: Fully expecting a minimum of a 50% run upon uplisting, based on the analogous uplisting performance of ONVO ($4 to $6), since both are hot biotech "theme stocks" with high public interest and front-runners in their respective markets. (ONVO a 3D medical play versus NVIV first company to cure acute spinal paralysis via a biopolymer implant.) CEO's uplisting 60-day window prediction falls within next 10 days.
$LSTMF: Based on recent oil price increases, revising PPS target to $11 (+50% upside relative to YTD chart low of $7.28), which is WITHOUT Keystone approval. Keystone approval catalyst will kick this to 100% upside ($15 price target).
$LSTMF: Target +50% upside off YTD chart lows ($11), WITHOUT Keystone approval. Keystone approval catalyst for 100% upside ($15 target).
$LSTMF: Devon Shire of SeekingAlpha just said, "Still holding Lightstream and actually quite happy with what they have done operationally. Canadian oil prices are exceeding Lightsteam's guidance for the year and it looks like production is as well."
Chart bottom oil play with 13 percent dividend, solid production in 3 canadian provinces.
http://seekingalpha.com/article/1535192-is-canadian-natural-resources-about-to-take-a-run-at-penn-west-energy
$LSTMF: At chart lows, accumulating here. 13% Divi, solid Canadian oil play producing in 3 provinces
Keystone pipeline approval will be Bakken catalyst. One stock set to run big on this trigger is Lightstream Resources (LSTMF - formerly known as PetroBakken, PBKEF). LSTMF is a Canadian oil stock with over 2000 producing wells within several large tracts of oil reserves across three provinces, including a large proportion of wells in the Bakken area that will benefit greatly from the Keystone pipeline.
A Chicago Tribune article last week noted that President Obama said he would approve the Keystone pipeline if it was determined that the pipeline was not expected to cause carbon pollution. This was a telling remark, since the March 2013 draft State Department report on the Keystone pipeline stated that the pipeline was not anticpated to produce adverse environmental impacts. At this point the State Department is just going through the routine motion of weeding out and responding to one million public comments, and is scheduled to release its final report this fall.
Since the market is forward looking, it will not wait until after the pipeline is constructed to price in the benefits of the Keystone pipeline. Instead, dozens of Bakken oil stocks will pop on this news in the fall. Meanwhile, LSTMF will pay a huge 13 percent dividend while we wait.
A Bakken oil stock at a 2-year chart bottom: $LSTMF.
Lightstream Resources (formerly known as Petrobakken - PBKEF) pays a huge 13 percent dividend while you wait for the Keystone Pipeline to be approved. The day the news hits, many Bakken oil stocks will run hard. LSTMF has over 2400 producing wells across three provinces and owns large geographic reserves in several areas. The PPS is within 15 cents of a chart double-bottom.
Obama announced last week (see Chicago Tribune article 2 days ago) that he would approve Keystone if it is determine that adverse environmental carbon pollution effects are not expected. That was an insightful remark, because in March of 2013 the State Department released a draft report on Keystone which stated that adverse environmental pollution impacts were not expected. Meanwhile, the state department is going through a routine process of weeding out and reviewing one million public comments, and is scheduled to release the final report this fall.
A chart bottom Canadian oil play set to pop on Keystone pipeline approval is Lightstream Resources (LSTMF - formerly known as Petrobakken - PBKEF). Current price is at a low not pierced since October 2011, with a huge thirteen percent dividend, steady quarterly production, and a huge number of wells and reserves compared to some of the smaller canadian oil stocks, all of the ducks are lined up for a HUGE run this fall when Keystone gets approved. Meanwhile, you get paid 13 percent to wait.
Chicago Tribune article from last week states Obama indicated he would approve Keystone if there were no anticipated adverse environmental carbon pollution effects. This was a very telling remark because the draft State Department report on Keystone from March 2013 stated that Keystone was not expected to produce adverse environmental effects. Currently the state department is just going through the routine motions of weeding out and responding to one million public comments, with the final report due out this fall.
Double chart bottom: $LSTMF (formerly PBKEF).
Watch this one when Keystone Pipeline gets approved this fall, will run for 50 to 70 percent gains. Meanwhile, investors get paid a 13 percent dividend to wait.
LSTMF operates a large number (over 2000) wells throughout three provinces, and owns reserves over a large geographic area, a substantial portion of which sits within the region that will benefit greatly from the Keystone pipeline.
The market is forward looking, so prices of Canadian oil stocks will rise immediately upon approval of the pipeline, not waiting for the actual construction to complete.
The Chicago Tribune reported last weekend that Obama stated he would approve Keystone if there are no anticipated adverse impacts on carbon pollution. However, that is a telling remark because three months ago, in March, the State Department released it's draft report on it's evaluation of the Keystone Pipeline, and basically stated they did not expect any adverse environmental pollution. Since then, the government is mainly going through the routine motions of weeding out and responding to over one million public comments. They expect to be finished and release a final report this fall.
Link to Chicago Tribune article:
http://articles.chicagotribune.com/2013-06-29/opinion/ct-edit-keystone-20130629_1_keystone-pipeline-ogallala-aquifer-pollution-impact
$LSTMF is new ticker for PBKEF: Strong Buy
Lightstream Resources (LSTMF), formerly known as PetroBakken (PBKEF), is a Canadian oil stock which now sits with a price at a double bottom on the charts (10/2011 to present), with a 13 PERCENT dividend, steady production, many producing wells over a large geographic area, and substantial reserves over three provinces.
So there is very little, if any downside risk here on LSTMF, and what is even more important, all the ducks are lined up for a HUGE run this fall when the Keystone Pipeline gets approved
The Chicago Tribune reported last weekend that Obama stated he would approve Keystone if there are no anticipated adverse impacts on carbon pollution. However, that is a telling remark because three months ago, in March, the State Department released it's draft report on it's evaluation of the Keystone Pipeline, and basically stated they did not expect any adverse environmental pollution. Since then, the government is mainly going through the routine motions of weeding out and responding to over one million public comments. They expect to be finished and release a final report this fall, so expectations are that the pipeline will be approved.
Meanwhile, investors in LSTMF get paid a 13 percent dividend to wait for this news. But when the news is released, the stock, along with dozens of other Canadian oil stocks, should pop at least 30 percent, with the more promising oil stocks such as LSTMF rising over a few weeks time by 50 percent to 70 percent.
Link to Chicago Tribune article:
http://articles.chicagotribune.com/2013-06-29/opinion/ct-edit-keystone-20130629_1_keystone-pipeline-ogallala-aquifer-pollution-impact
What's with all the bashers on the NVIV Yahoo board today? Looks like they are trying to affect sentiment and get price back down one last time to load the boat before uplisting. I would bet money the same guy or guys were long just a few days ago and sold between $4.00 and $4.50. But I will take advantage of the situation and add to my position if I see any serious dips, but frankly I kind of doubt it will happen unless volume really dries up. From the type of remarks posted, it looks to be biotech traders who are trying for multiple rinse and repeat cycles.