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SA Breaking News Team [] [] InVivo Therapeutics beats by $0.01 • 6:13 PM
SA Breaking News Team
6:13 PM (2 hours ago)
to me
InVivo Therapeutics beats by $0.01 • 6:13 PM
Mohit Manghnani, SA News Editor
InVivo Therapeutics (OTCQB:NVIV): Q3 EPS of -$0.04 beats by $0.01.
Langer and his next move
https://www.radcliffe.harvard.edu/event/2014-robert-s-langer-lecture
HAHA!Well Gary acts like a little child on all the boards I see him on and he is always entertaining.
garywoodruff, I'd call you an idiot, but that would be an insult to every idiot I've ever met.
Good luck!
Yes... new interm CEO...
Former Social Security fella...
http://www.ssa.gov/pressoffice/factsheets/astrue.htm
New CFO...
http://www.hotstocked.com/article/63812/invivo-therapeutics-holdings-corp-otcbb-nviv.html
and clinical plan set to begin Q1 2014, staggered and not all at once...
http://www.invivotherapeutics.com/2013/08/invivo-therapeutics-updates-clinical-plan/
Many have taken these changes negatively, and while it all did happen at once, I am happy with it in the long run. The old CEO, Reynolds was overly exuberant in timelines. He did a GREAT job in my opinion gettin the company to where it is now ie FDA approval for HUD status, FDA approval for human trials, securing financing for a state of the art manufacturing and research facility in MA, but it was time to pass the baton to people with experience in getting this thing from R&D to revenue generating which could still take some time and while they have enough cash to last until the end of 2014-beginning of 2015 (they are also debt free) the people involved have acces to private equity sources.
Again, anything could happen, but I am comfortable with this companies path.
Stalled uplisting to major exchange, CEO resignation, missed timelines for scaffold trials... that's basicaly it. Also the company is bad at communication. I am long this company and holding 3k shares. I've been trading this company for 1 1/2 years and love it.
Gary. I love u but please just shut up. Ur the epitome of scared money. So LONG.
Per NVIV site...
Sean Moran
Acting Chief Financial Officer
Mr. Moran joined InVivo in 2010 as Director of Finance and was named Acting Chief Financial Officer in August 2013. Prior to joining the Company, Mr. Moran served as CFO at Celsion Corporation, a biotechnology company, from 2008 to 2010, and as CFO of Transport Pharmaceuticals, a transdermal drug delivery company from 2006 to 2008. Mr. Moran brings a unique breadth of senior financial experience gained from 16 years of CFO experience with life science and technology companies, including Anika Therapeutics, Echo Therapeutics and SatCon Technology Corporation. Mr. Moran is a C.P.A. by training and holds an M.B.A. degree and B.S. degree in accounting from Babson College.
- See more at: http://www.invivotherapeutics.com/about-us/our-team/sean-moran/#sthash.V4XAgnWu.dpuf
Whoops! A little old...
Our new CFO
Via Bloomberg...
InVivo Therapeutics Names Sean Moran as Chief Financial Officer
InVivo Therapeutics Names Sean Moran as Chief Financial Officer
Business Wire
CAMBRIDGE, Mass. -- September 26, 2010
InVivo Therapeutics Corporation announced today that Sean Moran has joined
InVivo’s management team as Chief Financial Officer. In this newly created
position, Moran will play a key leadership role as the company continues to
drive the development and commercialization of its novel biopolymer
scaffolding device for the treatment of spinal cord injury.
Moran brings to InVivo more than twenty-six years of experience in financial
management and sixteen years as a CFO for public and private companies. He has
a deep background in life sciences and has served in senior financial roles
for medical device, biotech and drug development companies. Moran has
successfully raised capital and has extensive experience in corporate finance,
mergers and acquisitions, investor and Wall Street relations and SEC
reporting.
“InVivo has recruited world renowned scientists to our team and now the
addition of Sean Moran to the company represents the beginning of building out
of the business side of InVivo’s management team,” said Frank Reynolds, InVivo
Therapeutics CEO. “In just a short time with InVivo, Sean has already shaped
our financial strategies and we look forward to his continued contributions.”
“I am thrilled to have joined InVivo,” stated Moran. “The company’s technology
has tremendous potential to help treat patients with devastating spinal cord
injuries. InVivo’s product is moving into human clinical trials and the
company is poised for explosive growth.”
Before joining InVivo, Moran served as Chief Financial Officer of four
publicly traded companies, most recently at Celsion Corporation, as well as at
Sontra Medical, SatCon Technology Corporation, and Anika Therapeutics. Moran
was also the co-founder of Anika Therapeutics, and helped to take the company
public through an IPO and guided it to profitability. Mr. Moran is a CPA and
earned his M.B.A. and a B.S. in Accounting from Babson College.
It is going off of assumptions not fact. We just do not know. That is the risk and nature of any early stage company like this. No one, not myself, you, Napodano, Dr Langer, even the FDA, knows how this will play out.
This is just a summation of old news. That's why you saw no effect on the stock price.
Hydrogel FDA submission this year?
I know many people are waiting for the next shoe to drop on this being delayed, but I have a different take/hope on this. Might it be possible that the delay in the scaffold trials is so that we can sneak in a hydrogel submission to FDA and attempt to have that approved by the time the scaffold trials begin or are in process?
HAHA!!! I'm long and holding, but you have to be full of s%$!..
Holding with the utmost confidence! I am LONG. This means I am NOT a trader but an investor. Anything could happen though and I've not invested anything I cant stand to lose. Good luck everybody!
But what grounds legally?
Trials moved to 2014. Good thing in the long run in my opinion. The CEO has put together a solid timeline.
Where do you think we will stabilize? have we?
NVIV Updates Clinic Plan
CAMBRIDGE, Mass.--(BUSINESS WIRE)--August 27, 2013--
InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today announced an update on the clinical timeline for its biopolymer scaffolding to treat acute SCI. The Company now expects that, based on the judgment of new management, it will enroll the first patient during the first quarter of 2014.
Under the conditions of the FDA's approval of the Investigational Device Exemption, the five-person pilot trial will be staggered such that each patient will be followed for three months prior to requesting approval to enroll the next patient. Because the Company must obtain FDA approval to enroll each subsequent patient, the Company anticipates that from the date of the first enrolled patient, it will take at least 21 months to complete enrollment. Consistent with FDA guidance, the Company then expects to conduct a pivotal study with a control group to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption.
Michael Astrue, Interim Chief Executive Officer of InVivo, said, "We remain fully committed to beginning this study as soon as possible. While the study will take additional time, we look forward to bringing this important therapy into the clinic."
Further, management has undertaken a comprehensive project and timeline review of its hydrogel technologies platform, as well as its application to pain treatment, dural sealants, dural replacements, nerve conduits and fibrosis treatment, and will provide an update as to the status of those programs as data is available.
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, MA. For more details, visit www.invivotherapeutics.com.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties, and include statements regarding the Company's expectations with respect to the commencement of human clinical trials, the length of time to complete human clinical trials and conducting additional studies. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Institutional Review Board process, the Company's ability to obtain FDA approval to commercialize its products, the Company's ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company's products and technology in connection with spinal cord injuries; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in our filings with the SEC, including our Form 10-K and 10-Q's and our current reports on Form 8-K. We do not undertake to update these forward-looking statements made by us.
CONTACT: InVivo Therapeutics Holdings Corp.
Brian Luque, 617-863-5535
Director, Investor Relations
bluque@invivotherapeutics.com
SOURCE: InVivo Therapeutics Holdings Corp.
Copyright Business Wire 2013
Order free Annual Report for Invivo Therapeutics Holdings Corp.
Visit http://djnweurope.ar.wilink.com/?ticker=US46186M1009 or call +44 (0)208 391 6028
(END) Dow Jones Newswires
August 27, 2013 08:00 ET (12:00 GMT)
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New seeking ALPHA article...
Much more credible author too...
http://seekingalpha.com/article/1657842-invivo-therapeutics-reality-distortion-or-reformation?source=email_rt_article_readmore&app=1
Tweet convo where Zacks analyst proves Biotech Sage HUD pricing model is in error
(FROM YAHOO BOARD)
Here is the Teewhitter conversation wherein the Zacks analyst Jason Napodano proved Biotech Sage's pricing assumptions for the HUD device biopolymer scaffold was grossly wrong in its assumptions:
06-27-2013: Jason Napodano: "The HDE trial will start (eventually) and succeed b/c of the low hurdle for success. That's my call."
Biotech Sage: "The product will have no pricing power based on the HDE Trial. Reynolds asserts orphan pricing and does not blink for a second."
Jason Napodano: "Not true. HDE does not limit pricing power or profits. You need to read the new law put into place earlier this year."
Jason Napodano: "I spoke to the FDA-ORDP for about 60 min before I wrote this article to make sure I got the facts:"
Let us put this debate about profits under HUD to rest.
From the yahoo board...
The following information is taken from a presentation by Elizabeth Hillebrenner, Medical Device User Fee and Modernization Act (MDUFA) Reauthorization Coordinator at FDA.
Evolution over time
1990 SMDA: NO profit eligibility
2007 FDAA: profit eligibility for newly approved HDE devices labeled for pediatrics
2012 FDASIA: expansion of profit eligibility beyond pediatrics and to previously approved HDEs
The FDASIA amendments of 2012 allows for profits in the following situations:
If the device is intended for the treatment or diagnosis of a disease or condition that
occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs;
or does not occur in pediatric patients;
or occurs in pediatric patients in such numbers that the development of the device for such patients is impossible, highly impracticable, or unsafe.
The SA article conveniently omits the relevant amendments which expanded profits beyond pediatric use. Napodano is right about the misrepresentation about profits in SA article. Profits are allowed under a HUD.
If you do not believe me read the statute.
Section 613 of the Food and Drug Administration Safety
and Innovation Act (FDASIA) (Pub. L. 112-144), signed into law on July
9, 2012, amended section 520(m) of the FD&C Act. Under section
520(m)(6)(A)(i) of the FD&C Act, as amended by FDASIA, a HUD approved
under an HDE is eligible to be sold for profit if the device meets the
following criteria:
The device is intended for the treatment or diagnosis of a
disease or condition that occurs in pediatric patients or in a
pediatric subpopulation, and such device is labeled for use in
pediatric patients or in a pediatric subpopulation in which the disease
or condition occurs; or
the device is intended for the treatment or diagnosis of a
disease or condition that does not occur in pediatric patients or that
occurs in pediatric patients in such numbers that the development of
the device for such patients is impossible, highly impracticable, or
unsafe.
Haha! You people are so cute!
No! I'm sure the are busy as hell finalizing the next uplist submission and preparing that press release we will see before the bell Monday! Haha!
We can uplist below $4... Nviv should be an exception... Onvo was below on uplist as well if recall correctly.
Per investodepia...
Listing Requirements for All Companies
Each company must have a minimum of 1,250,000 publicly-traded shares upon listing, excluding those held by officers, directors or any beneficial owners of more then 10% of the company. In addition, the regular bid price at time of listing must be $4, and there must be at least three market makers for the stock. However, a company may qualify under a closing price alternative of $3 or $2 if the company meets varying reequirements. Each listing firm is also required to follow Nasdaq corporate governance rules 4350, 4351 and 4360. Companies must also have at least 450 round lot (100 shares) shareholders, 2,200 total shareholders, or 550 total shareholders with 1.1 million average trading volume over the past 12 months.
Well said. A lot of bashers like to pummel him, but if you look at the verifiable facts of where he has brought this company, you realize just how spectacular he really is. The Steve Jobs or biotech? It was time for him to pass the torch anyway (which may also be behind this). I wish him well!
THE NEW CEO...
Michael J. Astrue was sworn in as Commissioner of Social Security on February 12, 2007 for a six-year term that expires on January 19, 2013. The Social Security Administration is an independent federal agency headquartered in suburban Baltimore with over 62,000 employees nationwide. Commissioner Astrue reports directly to President Obama.
Commissioner Astrue is an honors graduate of Yale University and Harvard Law School. Early in his career, he worked for Senator Richard Schweiker of Pennsylvania and evaluated federal demonstration projects for both the National Council of Senior Citizens and a support center of the Legal Services Corporation. After law school, he clerked for the Honorable Walter J. Skinner in the Federal District Court of Massachusetts.
After working briefly for the Boston law firm of Ropes & Gray, he served as Acting Deputy Assistant Secretary for Human Services Legislation at the U.S. Department of Health and Human Services (HHS), Counselor to the Commissioner of Social Security, Associate Counsel to Presidents Reagan and Bush, and General Counsel of the U.S. Department of Health and Human Services. He successfully tried the first federal HIV discrimination enforcement case and successfully argued the first federal patient dumping enforcement case. While General Counsel of HHS, he had a concurrent appointment on the U.S. Architectural and Transportation Barriers Compliance Board during the period when the Board issued many of the first regulations under the Americans with Disability Act.
After a brief period as a partner of the Boston law firm of Mintz Levin, he worked for fourteen years in the biotechnology industry, most notably as General Counsel of Biogen and as the CEO brought in to lead the highly successful turnaround of TKT. He also taught biotechnology law and policy at Boston University and served as Chairman of the Massachusetts Biotechnology Council.
As Commissioner of Social Security, he has focused his efforts on reducing the disability backlog and improving service to the public, particularly through electronic services. He has spearheaded highly successful new systems for fast-tracking disability claims, created National Hearing Centers to reduce local backlogs with video hearings, and both expanded and overhauled the agency’s suite of electronic services to make them simpler, faster and far more user-friendly.
He has served as a member of the board of the Kenneth B. Schwartz Center, an organization whose mission is to support compassionate health care, as Vice Chair of the Massachusetts High Technology Council, and as a board member of a number of biotechnology companies. He has received numerous awards and honors, including the Public Health Leadership Award from the National Organization of Rare Disorders and the Humanitarian of the Year Award from the Alzheimer’s Association.
Commissioner Astrue is from Massachusetts. He is married and has two adult children
Could this solve corporate governance issues? Anyone smell uplisting?
Thanks for the old news we already knew about. These are timed sales and a very small piece of what he owns, and it does not bother me a bit.
From a normal NVIV basher on Yahoo Market Pulse...
"IR (investor relations) finally got back to us and said that appropriate steps have now been taken corporate governance issue wise and uplisting in tact."
http://finance.yahoo.com/marketpulse/NVIV