After being pointed toward a recent press release, it would seem that NVIV is attributing the delay in FDA approval of their IDE to manufacturing issues, primarily the construction of the GMP facility, followed by validation runs. They claim this will all be accomplished by Q1 of 2013.
First, if this is the case, why didn’t they state that back in 2011 when the IDE was placed on hold by the FDA?
Irrespective of that, there is a much bigger issue here. Any material destined for human clinical trial use must undergo preclinical toxicology testing prior to initiation of a clinical trial. Any preliminary studies performed with material manufactured under different conditions (i.e. different manufacturer or non-GMP) or under different release criteria MUST be repeated with actual GMP material. Also, 3 months of stability data must be provided to FDA prior to initiation of clinicals. Generally all of this data is supplied to FDA as part of the IDE. To file an IDE without this data means that what NVIV provided to FDA was a manufacturing “plan”. If NVIV has not yet manufactured the actual GMP clinical material yet there is absolutely no way they will be approved to initiate the trial in early 2013. We are looking at no less than 6 months, minimum, given that the tox work needs to be done in primates. And this all assumes that i) they are able to manufacture at least three lots of material that all meet specification, and ii) no clinically significant adverse effects are found during the preclinical tox. No guarantees on either of those. Most companies would have outsource manufacture of a material like this to a CMO with experience; there are plenty out there that are relatively cheap, fast and qualified. Investing in a manufacturing infrastructure this early is very risky.
These missteps by NVIV are significant and amateurish. Not surprising given that the person responsible for all daily operations, including facilities and regulatory affairs, is a 26 year old English major with no substantial experience in the field other than previously being the personal assistant to the CEO. The problem with NVIV is not the technology or the application, but the management. Put the right people at the top and this technology might work. With the current management it will certainly fail. This is exactly the point made by the SA article and the point I have been making for some time. I despise Frank Reynolds for what he is doing at NVIV; screwing over investors and squandering a technology that might work for personal gain.
Proceed with the ad hominem attacks on me now.
Tdarren I have have my own Hunches as to your motivation, but I see you as an invaluable perspective on NVIV to be sifted and weighed with other sources.
I did close my position some time ago based on your posts at the time, thus avoiding the precipitous tumble.
Back then, you seemed pessimistic on the product itself, now you seem more less so.
Do you ever worry about lawsuits?
Do you think your views might be a little excessive due to possible animus of some sort?
Just curious.......and I am serious when I ask how you come to have so much knowledge. I am a new investor and try to study a company and their products as much as possible. That of course means checking into management as well. I know you referenced that you know a former employee of NVIV and that he/she has given you information. I'm just trying to understand if I should have come to the same conclusion as you have and therefor.....where did I go wrong?
Do you work in this field, or did you work for the FDA? Any suggestion may enlighten my approach.
Sentiment: Strong Buy
KC: I'm trained as a clinical researcher with a focus in neurology but have spent the majority of the past 20 years in the biotech field. I have led a number of regenerative medicine programs in neurological indications (including spinal cord injury), cardiovascular disease, wound healing and oncology. I have had numerous interactions with the FDA as a sponsor representative as well as a consultant. I'm currently an independent consultant and am involved in about a dozen different projects right now. I don't think you've missed anything with NVIV; rather, I think NVIV has misrepresented themselves as having much more than they really do. It's my opinion based on my experiences. And, in full disclosure, I have worked with Frank Reynolds in the past and feel that he is ill-suited for the job he has. All opinion. Traditionally companies like NVIV are privately held and/or held by venture capital firms that are fully aware of the risks involved. In this case, due to their RPO, retail investors have access to this ticker and, in my opinion, are being manipulated because in large part they lack the experience to adequately #$%$ the risk involved. NVIVs technology might or might not be sound, but their management is clearly unsound, in my opinion.
If, if if if if, if...
No ad hominems deserved. You have been civil and you've made some valid points. Especially in the second paragraph. I agree this company has been poorly managed and the submittal to the FDA was incomplete and to a certain extent amateurish. Hopefully they learn from their mistakes as they move forward.
You do seem to have too many "if's" and unsubstantiated assumptions in the first paragraph. They may already be in the midst of the stability study. Respectfully, I seriously doubt you're correct about the being required to repeat the newer material with primates again. It is either flatly not required or they may have received a waiver (possibly as part of the HUD/HDE meeting) because it would be unconscionably negligent of the company not to have announced something that huge. Think about it. Allegedly the company has a 3D printer which is able to produce the scaffold material (which they may have had for some time, such as for the last study) and I doubt manufacturing needs to be farmed out. I am still of the belief that this could occur as early as Q1, but frankly I did hear from a respected source that it could be as late as June due to scheduling with the medical centers.
There are three hospitals in Boston less than 10-miles away from MIT & Invivo Therapeutics from which two of the current directors are associated . How be it that scheduling 5-patients should be such a concern? This trial isn't processing one hundreds of people, only five...
If you doubt the need for testing I describe, consult the FDA regulations. Suitability of material for GLP animal studies in support of IDEs/INDs is clearly stated in CFR Part 58. My point is exactly as you state: they are seriously negligent.
"Any material destined for human clinical trial use must undergo preclinical toxicology testing prior to initiation of a clinical trial"
The polymer NVIV is using in their scaffolds has already been approved by the FDA previously--it dissolves into H20 and C02 in the human body---their is no need for "toxicology" testing
Sentiment: Strong Buy
You are absolutely incorrect. Toxicology testing is mandatory; even if this compound has been used before, the material NVIV is making themselves has never been tested, nor has it been tested for safety after injection into spinal cord. Even cosmetics are subject to FDA toxicology testing. Misinformation such as your post do nothing but harm. Get your facts straight before you post nonsense.