– Cost of care for the first year post-SCI: $340K - $1.0M+
– Net present value of a quadriplegic injured at 25 for life: $4.6M+
National Spinal Cord Injury Statistical Center, Facts and Figures at a Glance. Birmingham, AL: University of Alabama at Birmingham, February 2015
Perrin talked about this conversation with insurers back in 2014....didn't give a price, but I assume the low end of their projections in the presentation accounts for that conversation.
envy, you're in the middle of the range. At the end of the day, insurance companies are going to determine the price. We've all seen estimates on the cost. Last year, Perrin had mentioned that he already talked to insurers. Based on the numbers the company states, low end is $48,000, but as Perrin stated, it really depends upon the amount functional gain that the scaffold can demonstrate. Zacks still likes $150,000. But in noway will this go for $3K,
Another company I'm invested in was told by a Massachusetts Insurer that they would pay $100K for their scaffold. At the end of the day, it's an insurer question--and they will be looking at quality of life issues and how how much the scaffold will save them over the life time of a SCI patient. At the end of the day, the savings from an insurers point of view will be much more than $2,500.
"Before surgery, only 2 participants walked 10 meters with assistance and did not need assistance for bladder or bowel care before surgery. The rest could not walk or do their bladder and bowel care without assistance."
So the Chinese had 2 complete SCI patients in their trial that could walk--your words not mine. I wonder if they were included in the results of people that could walk 10 meters...
Although the previous trials you mention are on the clinical trials web site, they were not FDA based trials. The database is an international clinical trials database. The UCBMC trials you refer to are under the authority of the China: Ethics Committee and not the FDA. It is highly unlikely the FDA will accept the trial results from China. Unfortunately the FDA doesn't have any reciprocity agreements with foreign countries and if they did, China wouldn't be on the list of accepted partners.
This is why NVIV made an intelligent move by incorporating Canada and Europe into its study. Why? They know the FDA will accept results from these countries because the authority for the trials is the FDA and meets FDA requirements. So the INSPIRE results will be able to be used to get approval in those countries as well as the FDA--because NVIV will ensure the study meets those countries requirements. So what does this all mean? Well, since Europe doesn't have a HUD equivalent for devices, the use of the scaffold will be much broader than it will be in the U.S with respect to acute SCI. Europe has about 500 million people. U.S around 320 mill. Incident rate 12,500 per year acute. Using the U.S. incident rate for acute, 12,500/320 mill X 500 mill, indicates that Europe would have approximately19,531 acute patients per year.
Another company I follow has had to perform trials in Australia, China, Europe and the U.S because of the reciprocity issue. I see no difference for any company that was willing to use the Chinese technology. The info you cite are a nonissue for NVIV
"The WISCI is a measure of ambulation designed specifically for SCI clinical trials. The WISCI evaluates the amount of physical assistance, BRACES OR DEVICES required to walk at 10m."
imamisanthrope, you're neither ignorant or stupid, but rather blinded by either your hatred for this company or your short position or both. You may not like it, but using braces or a device is walking. Oxford Dictionaries -- "move at a regular and fairly slow pace by lifting and setting down each foot in turn, never having both feet off the ground at once:" Definitions doesn't say you can't have a brace or device.
Here's the links to trials associated with the paper you posted.
Both studies were completed in 2014, yet there isn't any Phase 3 trial. Unless the Chinese can find a company to support their research to commercialization, it isn't happening.
They also have the same problem NVIV has, how much of any conversion is attributed to known statistics...
"The majority of subjects (94.4%) who had a neurologically complete injury at 1 year remained complete at 5 years postinjury, with 3.5% improving to AIS grade B, and up to 1.05% each improving to AIS grades C and D. There was a statistically significant change noted for MIS. There were no significant changes for the motor level and NLI over 4 years; however, approximately 20% of subjects improved their motor level and NLI. People with complete and incomplete injuries had similar improvements in motor level, but subjects with an incomplete injury had a greater chance of improvement in NLI and MIS."
Good luck with your short position--knowledge is power!
From the paper...."We conclude that UCBMNC transplants and locomotor training improved WISCI and SCIM."
Now some facts.....
"The WISCI is a measure of ambulation designed specifically for SCI clinical trials. The WISCI evaluates the amount of physical assistance, braces or devices required to walk at 10m."
So you should not infer that people are actually walking without assistance. You stated "Motor return, B&B, walking scores...very impressive." You could say the exact same thing about NVIV patients one and two! Since the study isn't powered to measure WISCI, we really couldn't compare studies, but I would venture to say that if NVIV provided the $$$$$$ for physical therapy, NVIV would have similar or better WISCI scores.....
Sentiment: Strong Buy
I'm really happy for Jesi Strachem as she seems to continue to improve. This Today article seems to indicate Jesi, Patient 2, is continuing to improve after 1 year. Her injury was at T-7, her upper back. Unfortunately, with respect to the study, she's beyond the 1 year mark. However, the company will monitor the patients in the study for the rest of their lives and if she converts, I bet we will hear about it. I hope she does.
"Part of Stracham's story is that she was actually the second person to undergo an experimental surgery that targeted the hole in her spine. A year later, Stracham is slowly, but surely, starting to regain feeling in her legs and back. She said her legs are always sore and tingling, and she's experienced extreme pain in her lower back — a sign her doctors say is actually a good one."
I appreciate when people provide news and their insight on a stock I own--both positive and negative--holiday, weekend--doesn't matter.
He's been the Chief Medical Officer at HART since April 2014 (2 years ago). He was promoted to executive Vice President in August 12, 2015 (7 months ago). That's when I bought my $0.91 shares. I bought some of my shares on the 13th. Bought more as insiders bought in August. He got the extra benefits for his performance--not for some anniversary date--that would be August 2016 The 8-K says he got the benefits because of performance--I choose to believe the 8-K. I've had a couple of bad apples where companies bend the truth to the point where they almost invite a lawsuit, but this isn't one of them--and in one case there was a lawsuit--but it was a biotech company. Seems as if you may have had some bad apples in your day, but I don't believe HART is one.
You don't give all this compensation to a person you intend to fire because of poor performance with a month and half time left when you are about to release results that could make or break the company. LOL In this case, the results (CMO performance) will MAKE the company.
is the biggest tell you'll get prior to the conference call in mid-May.
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
"As modified, the Agreement provisions also now conform to the respective provisions of the Company’s employment agreement with Thomas McNaughton, its Chief Financial Officer. Prior to the modifications, the Agreement provided for termination payments in the above described scenarios based on six months of Mr. LaFrancesca’s current base salary. Following the Amendment, (i) the change of control termination payment is now based on Mr. LaFrancesca’s most recent annual base salary plus most recent annual cash incentive compensation, and (ii) for termination by the executive for good reason, by the Company without cause, the payment is now based on the sum of his average annual base salary for the prior three fiscal years or annual salary for the prior fiscal year, whichever is higher, and his average annual cash incentive compensation for the prior three fiscal years or annual cash incentive compensation for the prior fiscal year, whichever is higher."
Bottom-line, the good doctor is doing stellar job and the company does not for see letting him go because of said performance since November. Do you actually need to see the data? LOL
You don't expend money on personnel resources unless you know you are going to need them. The only blowhard that I've ever come across is Frank Reynolds the former CEO of NVIV. This CEO did not use terms like expect back in November, December or January. They've got 16 pigs under the belt so they now are using a verb like expect and adjectives like compelling since they have preliminary results. That's my opinion based on my experience. I respect yours. Thanks.
Sentiment: Strong Buy
Well, this sounds like a lawsuit..."Changes at InVivo Therapeutics after I left the company in August of 2013 have PERMANENTLY limited wide market adoption of my first generation of NeuroScaffolds." But you have to show injury to even sue someone. Looks like the price hardly even moved--no injury there. The market showed what it thinks about Frank's statements. But if he keeps spouting such nonsense, he'll need a lawyer on standby since can't let go of the past. Frank was miraculously healed and was able to come out of retirement really quickly to start up PixarBio or was it even his alleged illness that caused him to retire from NVIV to begin with...LOL...I think not........LOL....
I agree. Small biotechs don't make statements like "expect" or "to develop compelling data in support of its goal of filing an Investigational New Drug (IND) application" when issuing an 8-K. The last thing they want is some silly lawsuit for overstating possible results of a trial. The "game" is usually played by companies making conservative statements in order to temper expectations; however, I'm convinced that HART has seen, not documented, enough "data" from the 16 pigs thus far to know that they will pass the FDA requirements and that the data will be "compelling." I hope the company is able to get FDA approval to recruit patients for compassionate use of the scaffold. The call last night was another big tell. Don't listen to the noise on this board. It is okay to have a negative opinion on a stock, so I just listen to people who make rationale arguments and not school yard tactics. I myself have told people to get out of a stock using objective data and information--not just get out because I know better than you or I have a short position. With any biotech it's about one thing and one thing only when it comes to trials--the data. And the data can make or break a small biotech.
"Good, I can feel your anger. I am defenseless. Take your weapon. Strike me down with all of your hatred and your journey towards the HART side will be complete!"
Sentiment: Strong Buy
I agree with your price and assessment. They know what the data is. Companies in this game don't use words like "expect" unless they expect. Biggest tell I've seen in long while. Been loading up in the depressed HART market.
Sentiment: Strong Buy