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post #101 of 295

Just grabbed some more at $2.15... couldn't help myself.  Remember this is the same price area where they previously had two private offerings.  It should hold around here unless of course there is negative news from tomorrow's meeting.  Most of the selling this week and last has been on relatively low volume compared to the drop it caused in price.  If news from the meeting is positive, I think we easily see $3+ again...

 

Quote:
Originally Posted by Fizz1030 View Post

Here's a post I found on the Yahoo board (so please take with a grain of salt):

 

"I have been in contact with Frank Reynolds and he tells me the company would not have any comment until it receives the FDA's official decision after the meeting which should be within 30-60 days.
So no reason to hold our breath on this for a while.
Share price may stagnate or slide again for a few more weeks.

Bob"

 

According to this poster, Frank indicates that they expect an official decision on the trials soon after this meeting.  At 2.25 x 2.28, I may have to grab some more shares.  However, it could very well go lower if we don't get news for a while...

 



 

post #102 of 295
Thread Starter 

I've got my bids still placed and looking to buy between $2.00 to $2.12ish from impatient traders. I'm investing in this stock and there has been no material change in the fundamentals. 
 

Quote:
Originally Posted by Fizz1030 View Post

Just grabbed some more at $2.15... couldn't help myself.  Remember this is the same price area where they previously had two private offerings.  It should hold around here unless of course there is negative news from tomorrow's meeting.  Most of the selling this week and last has been on relatively low volume compared to the drop it caused in price.  If news from the meeting is positive, I think we easily see $3+ again...

 



 



 

post #103 of 295
Thread Starter 

We broke support at the 50dMA and are no trading along the lower Bollinger band.  Next strong support near $2.00
 

Quote:
Originally Posted by amohedas View Post

We're holding the 50dMA and lower Bollinger band as support. Consolidating nicely with the BBs tightening up.  

Obviously two options: 1) Break down and catch support at about $2.00 or 2) Break to the upside above $2.70 and make a run for $3 and a blue sky breakout

 

I think the outcome of the FDA meeting will be the catalyst for 1 or 2.

 

stock-chart-str.aspx?id=NVIV&ca=1159464616



 

post #104 of 295

News out on the meeting... Looks like everything is moving along as expected, albeit a bit slowly.  The press release doesn't give many details but does reiterate the company still expects approval and to begin the human trials in 2012 pending final approval from the FDA via an "open dialogue" process.  I just hope the FDA will approve the filing this year without delay.

 

InVivo Therapeutics Expects to Commence Human Study after Meeting on IDE Filing for Biopolymer Scaffolding to Treat Spinal Cord Injuries

 

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), announced today that it held a meeting with the U.S. Food and Drug Administration (“FDA”) in which they discussed the Investigational Device Exemption (“IDE”) application previously filed by InVivo for its biopolymer scaffolding to treat acute spinal cord injuries.

Following the meeting, the Company is expecting the biopolymer scaffolding device to be regulated under the Humanitarian Use Device/Humanitarian Device Exemption (HUD/HDE) pathway. Before human clinical studies can commence, the FDA must approve the Company’s IDE filing, for which the FDA has agreed to an open dialogue as part of the final process toward gaining approval. During the FDA meeting, the Company addressed several points in the FDA’s feedback including the proposed design and clinical protocol for the study.

“This is a significant step for all patients waiting for first in-man data using biomaterials for spinal cord injuries,” said Frank Reynolds, InVivo’s Chief Executive Officer. “We are pleased that our core team of multidisciplinary scientists, led by my partner, Bob Langer, has had the opportunity to meet with the FDA to discuss our platform technology. We are encouraged by the communication we have had with the FDA to this point, and pending approval of the IDE, we expect the clinical trial for our treatment of acute spinal cord injuries to commence during the second half of 2012.”

Later in 2012, the Company plans to submit hydrogel-based applications to the FDA for the treatments of SCI and chronic pain. As the industry of cell-based therapies advances, InVivo also intends to leverage the Company’s acute SCI treatments to expand to chronically injured patients. InVivo has pioneered a new treatment that uses a biocompatible polymer-based scaffolding to provide structural support to a damaged spinal cord in order to spare tissue from scarring while improving recovering and prognosis after a traumatic SCI. Today, there is no effective treatment for the spinal cord for paralysis caused by SCIs, and the market potential for acute SCI is estimated to be over $10 billion.

 

http://finance.yahoo.com/news/invivo-therapeutics-expects-commence-human-100000815.html

post #105 of 295
Thread Starter 

They couldn't really have been much more specific given all the BS one has to deal with when getting approval from the FDA.  Sounds like the meeting was basically to hammer out some of the details on the trial protocol itself not about whether or not the technology is even legitimate etc.  This is big IMO and I expect approval for the trial to move forward within the next few months (the FDA is excruciatingly slow).

 

Also I like the fact that NVIV is moving forward on the other products as well. Fundamentals remain intact.
 

Quote:
Originally Posted by Fizz1030 View Post

News out on the meeting... Looks like everything is moving along as expected, albeit a bit slowly.  The press release doesn't give many details but does reiterate the company still expects approval and to begin the human trials in 2012 pending final approval from the FDA via an "open dialogue" process.  I just hope the FDA will approve the filing this year without delay.

 

post #106 of 295

My only regret is not grabbing more shares yesterday at the discounted prices, oh well.  I'll save my dry powder for the next round of impatient investors...  It looks like part of this drop was due to Frank selling around 260-270k shares last week (filing came out yesterday).  Not a big deal in the big picture, he owns 14million shares, so cashing in a few here and there is to be expected.  It also creates nice buying opportunities for the rest of us biggrin.gif.  Back up to $2.50 today already... not too shabby.

 

Quote:
Originally Posted by amohedas View Post

They couldn't really have been much more specific given all the BS one has to deal with when getting approval from the FDA.  Sounds like the meeting was basically to hammer out some of the details on the trial protocol itself not about whether or not the technology is even legitimate etc.  This is big IMO and I expect approval for the trial to move forward within the next few months (the FDA is excruciatingly slow).

 

Also I like the fact that NVIV is moving forward on the other products as well. Fundamentals remain intact.
 

 



 

post #107 of 295
Thread Starter 

Exactly Fizz.  Basically if any investor wants to come into the open market and buy a significant amount of shares it drives the price up ... and fast!  This is great because it means institutions will be forced to buy via private placements which will result in higher share price and a stronger base of support.


Shares are being held very tightly and the market is not too liquid so that gives small investors like us the ability to accumulate shares at discounted prices without affecting the PPS very much.

 

This is going to be a fun stock to own me thinks.  booyah.gif
 

Quote:
Originally Posted by Fizz1030 View Post

My only regret is not grabbing more shares yesterday at the discounted prices, oh well.  I'll save my dry powder for the next round of impatient investors...  It looks like part of this drop was due to Frank selling around 260-270k shares last week (filing came out yesterday).  Not a big deal in the big picture, he owns 14million shares, so cashing in a few here and there is to be expected.  It also creates nice buying opportunities for the rest of us biggrin.gif.  Back up to $2.50 today already... not too shabby.

 



 



 

post #108 of 295

Is anyone able to get a quote on NVIV this morning?  My Ameritrade is not showing any trading.  Is it halted?

post #109 of 295

I saw this interesting article on the BBC today.  It looks like some UK researchers are thinking along the same lines as InVivo, giving credit to Frank's theory about how to help the spinal cord tissue regenerate.  They have only just begun experimenting in rats though.  Looking forward to the pending human trials.

 

http://www.bbc.co.uk/news/health-17783160

 

Miniature honeycomb 'grows nerve'

nerves
A "miniature honeycomb" - or scaffold - could one day be used to encourage damaged nerves to grow and recover, according to an international group of researchers.

The scaffold can channel clusters of nerves through its honeycomb of holes, eventually healing a severed nerve.

The findings of their study on mouse nerves are published in the journal Biofabrication.

Academics hope to one day treat spinal cord injuries with the scaffold.

When nerves are severed, such as in car accidents, it can result in a loss of feeling and movement.

Repairing this damage can be a challenge - but nerves outside of the brain and spinal cord can repair themselves, if only over short distances.

Tube links

One technique to improve this repair is to use tubes. Either end of the severed nerve is placed in a tube and the two ends of the nerve should grow and join in the middle.

Researchers at the University of Sheffield and Laser Zentrum Hannover, Germany, investigated using a honeycomb structure.

Dr Frederik Claeyssens, from the department of materials science and engineering at Sheffield, told the BBC: "That is much more like the structure of the nerve itself.

"The nerve has small regions of 'cable' that go through from one end to the other end, you have a whole bunch of little cables inside a larger cable, that's what we tried to reproduce with this type of scaffold."

The honeycomb is made from photopolymerizable polylactic acid, which biodegrades once the nerve has repaired.

The researchers showed nerve cells could grow on the scaffold and are now testing it in mice to see if it can fully repair the damage.

Dr Frederik Claeyssens said: "This technology could make a huge difference to patients suffering severe nerve damage."

Scaffold technology is used in a range of "regenerative medicines". Building a scaffold and then coating it with human cells has, for example, been used to give patients new windpipes and bladders.

post #110 of 295
Thread Starter 

Very interesting.  It is good to see other scientist corroborating the work that Dr. Langer, Frank, and InVivo have done. 

 

The 50dMA seems to be providing resistance at $2.45....still forming a very solid base a these levels.

post #111 of 295

Looks like they are working under the assumption that they already have a green light from the FDA on human trials thumbup.gif

 

InVivo Therapeutics Adds Senior Leadership in Manufacturing and Cell Research

8:58a ET May 11, 2012 (Business Wire)

InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), announced today the appointment of Jack Harvey as Senior Director of Manufacturing and Celina Chang as Senior Scientist as the Company ramps up preparations for a human clinical trial and begins to expand its product portfolio to other nervous system conditions.

Mr. Harvey will lead InVivo Therapeutics' production of GMP polymer-based biomaterial technologies. Leveraging his seven years as the Director of Manufacturing at Pervasis Therapeutics, Inc., where he led combination biomaterial and cell therapy products through the FDA, Mr. Harvey will lend his knowledge to InVivo's existing and future product pipeline. He will manage contracted and internal resources as well as Chemistry, Manufacturing and Control (CMC) development and manufacturing scale up. Mr. Harvey received his B.A. in biology from Harvard University and his M.P.H. Health Law from Boston University, School of Public Health.

"I'm excited to lead InVivo's optimization of GMP biomaterial technology manufacturing processes," Mr. Harvey said. "Spinal cord injury treatments are a very promising field, and I'm eager to provide patients with viable solutions for SCI and other nervous system disorders."

Ms. Chang also previously worked at Pervasis as a scientist charged with process improvement for the company's three-dimensional polymer matrix embedded with cells. At InVivo Therapeutics, Ms. Chang will lead the execution and review of experiments per GMP and GLP regulations, and undertake the analysis of various cultured cells for InVivo's chronic spinal cord injury therapies. Prior to Pervasis, Ms. Chang worked at Ortec International, focused on advancing regenerative medicine and stem cell therapies. She holds a B.S. in biological engineering from Cornell University.

"We strongly believe that combination therapies are the future of chronic spinal cord injury, and I look forward to developing these technologies," said Ms. Chang.

Said InVivo Chief Executive Officer Frank Reynolds, "InVivo is at an inflection point in our growth, and adding industry leaders like Jack and Celina will take our platform technology in new directions. We are creating a new paradigm in the treatment of neurological injuries, and as our team evolves we are pleased that we continue to attract the best in our business, enabling us to expedite our products to market."

For more information about InVivo Therapeutics' technologies, visit www.invivotherapeutics.com.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is focused on utilizing polymers as a platform technology to develop treatments to improve function in individuals paralyzed as a result of traumatic spinal cord injury. The company was founded in 2005 on the basis of proprietary technology co-invented by Robert Langer, ScD. Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who is affiliated with Massachusetts General Hospital. In 2011, the company earned the prestigious David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. The publicly traded company is headquartered in Cambridge, Mass. For more details, visit www.invivotherapeutics.com.

 

post #112 of 295
Thread Starter 

Very light volume moving the stock to the $2.45-$2.50 area.  On an FDA approval of the clinical trial this is going to fly above $3 and fast.  Not many shares for sale at these levels.

 

The consolidation is looking good.

post #113 of 295
Quote:
Originally Posted by amohedas View Post

Very light volume moving the stock to the $2.45-$2.50 area.  On an FDA approval of the clinical trial this is going to fly above $3 and fast.  Not many shares for sale at these levels.

 

The consolidation is looking good.

 

There's definitely strong support between 2.15-2.20.  I'm pretty confident this area holds seeing as how they had two previous offerings right around 2.10/share.  Once volume picks up I bet this will move quickly from these levels.  I am considering going to the annual meeting next week on 5/30 since I am close by just to see if they have anything new to say on the trials.

post #114 of 295
Quote:
Originally Posted by Fizz1030 View Post

 

There's definitely strong support between 2.15-2.20.  I'm pretty confident this area holds seeing as how they had two previous offerings right around 2.10/share.  Once volume picks up I bet this will move quickly from these levels.  I am considering going to the annual meeting next week on 5/30 since I am close by just to see if they have anything new to say on the trials.

 



Fizz,

 

I have never attended a shareholders meeting but am really excited about InVivo and was thinking of attending.  Have you ever been to one and would say if its worth the trip?

 

I am concerned with this.... Will people likely be turned away?

 

Admission of shareholders to the Annual Meeting will be on a first-come, first-served basis, and picture
identification will be required to enter the Annual Meeting. An individual arriving without picture identification
will not be admitted unless it can be verified that the individual is an InVivo shareholder. Use of cameras,
cellular phones, recording equipment and other electronic devices will not be permitted at the Annual Meeting.
We reserve the right to inspect any persons or items prior to their admission to the Annual Meeting.

 

Only shareholders of record as of the close of business on Wednesday, April 18, 2012 are entitled to notice
of, and to vote at, the Annual Meeting. All shareholders are cordially invited to attend the meeting.

 

How do they know I am a shareholder?

post #115 of 295
Quote:
Originally Posted by weitzwb24 View Post

 



Fizz,

 

I have never attended a shareholders meeting but am really excited about InVivo and was thinking of attending.  Have you ever been to one and would say if its worth the trip?

 

I am concerned with this.... Will people likely be turned away?

 

Admission of shareholders to the Annual Meeting will be on a first-come, first-served basis, and picture
identification will be required to enter the Annual Meeting. An individual arriving without picture identification
will not be admitted unless it can be verified that the individual is an InVivo shareholder. Use of cameras,
cellular phones, recording equipment and other electronic devices will not be permitted at the Annual Meeting.
We reserve the right to inspect any persons or items prior to their admission to the Annual Meeting.

 

Only shareholders of record as of the close of business on Wednesday, April 18, 2012 are entitled to notice
of, and to vote at, the Annual Meeting. All shareholders are cordially invited to attend the meeting.

 

How do they know I am a shareholder?

 

Hey Weitzwb24,

 

I have also never actually attended a shareholder meeting before, but I would assume you would be admitted as long as you have a photo ID and you owned shares as of April 18th as they stated.  I assume they will have a list of all shareholders on record as of 4/18 and then just check your photo ID to that list.  I'm not sure how big the room is where they are holding the meeting, but I doubt they would need to turn people away unless attendance was unexpectedly large.  I'm not sure if there will be any update on the business though (other than what we already know through press releases) as the schedule released in the proxy filing only lists the issues to be voted on:

 

To the Shareholders of InVivo Therapeutics Holdings Corp.:

Notice is hereby given that the Annual Meeting of Shareholders (the “Annual Meeting”) of InVivo Therapeutics Holdings Corp., a Nevada corporation, will be held on Wednesday, May 30, 2012 at 10:00 a.m., local time, at our corporate offices located at One Broadway, 14th Floor, Cambridge, Massachusetts 02142, for the following purposes:

 

 

  1. To consider and vote upon a proposal to elect one Class I director to hold office for a three-year term ending at the annual meeting of shareholders in 2015 and until his successor is duly elected and qualified;

 

 

  2. To consider and vote upon a proposal to approve and adopt an amendment to our 2010 Equity Incentive Plan to increase the number of shares of common stock available for issuance thereunder from 3,500,000 shares to 6,500,000 shares;

 

 

  3. To consider and vote upon a proposal to ratify the appointment of Wolf & Company, P.C., an independent registered public accounting firm, as the independent auditor of our company for the fiscal year ending December 31, 2012; and

 

 

  4. To transact such other business as may properly come before the Annual Meeting or any adjournments or postponements thereof.

The Board of Directors has no knowledge of any other business to be transacted at the Annual Meeting.

post #116 of 295

I would attend not to gain any info, but more just to experience a shareholders meeting.  I have never owned such a large part of a company as InVivo and would be interested in learning some of the other sides of owning a stock.  I mean if you owned shares of GE you would likely never make it to the meeting. 

 

The drive is only about three hours for me; seems like it could be an interesting learning experience.

post #117 of 295
Quote:
Originally Posted by weitzwb24 View Post

I would attend not to gain any info, but more just to experience a shareholders meeting.  I have never owned such a large part of a company as InVivo and would be interested in learning some of the other sides of owning a stock.  I mean if you owned shares of GE you would likely never make it to the meeting. 

 

The drive is only about three hours for me; seems like it could be an interesting learning experience.

 

Looks like they will also be broadcasting the meeting online:

 

http://finance.yahoo.com/news/invivo-therapeutics-announces-webcast-annual-202500821.html

post #118 of 295
Quote:
Originally Posted by Fizz1030 View Post

 

Looks like they will also be broadcasting the meeting online:

 

http://finance.yahoo.com/news/invivo-therapeutics-announces-webcast-annual-202500821.html

 



I have decided to attend.  The only problem I now have is the webcast says 9am and the proxy statement says 10am.....

post #119 of 295
Quote:
Originally Posted by weitzwb24 View Post

 



I have decided to attend.  The only problem I now have is the webcast says 9am and the proxy statement says 10am.....

 

Yeah I saw that, I would call the investor relations # on their website to clarify the time if you are going to attend.  I will probably end up watching online.

post #120 of 295

Out of curiousity, I was doing some reading on the SCI human trials Geron Corp. had been working on a couple years ago prior to ending their SCI studies.  I decided to play around a bit with the numbers to see what kind of valuation we might expect as InVivo moves further along with the FDA approval process...

 

On January 23, 2009, Geron Corp. got approval from the FDA to begin human clinical trials using stem cells to treat patients with Acute SCI.  That day and during the weeks preceding the announcement the share price went from $5 to a high of $8.50, representing an increase of almost $300 million in Geron's market value.  Of course Geron's SCI treatment approach was different from InVivo's, but if we assume that the market would place the same valuation on an FDA go-ahead for InVivo's SCI human trials, that would yield a jump in share price of $4.70 ($300 million / 64 million O/S) based on the value of these trials alone (the increase could also be more/less depending on what was "built-in" in Geron's share price prior to the FDA approval and what is currently "built-in" in InVivo's share price).  Who knows what kind of price appreciation we'll see with InVivo as we approach the human trials, but I thought this was an interesting comparison.

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