It's been a while since I was chased off of this board but decided to check back in after bumping into a (recent) ex-employee of NVIV at a regen med conference in Fla. earlier this week. Had a very interesting conversation but won't violate his confidence by posting here. After reading down some of the posts over the past 6 or so months since I left, it's clear that many posters here (which I assume are also investors) don't understand the process by which FDA approves clinical trials such as the one requested by NVIV, so here it is:
The product being developed by NVIV for acute SCI is regulated as a medical device and it's final approval for use in humans is subject to what is called 510k approval. Some devices don't require clinical trials prior to submitting a 510k application (like some cardiac defibrillators, for example), but NVIV's scaffold does require them (for a number of reasons). In order to start clinical trials for a device, an IDE application is submitted to FDA for review. The IDE contains information in 3 main areas: manufacturing, preclinical toxicology and clinical trial protocol. The FDA has 30 days to review the IDE application (this is Federal Law and I can assure you that FDA always meets this deadline, almost always replying on day 29). The FDA has several options: they can allow the trial to proceed with no additional information or studies required (uncommon, maybe occurs 20% of the time), they can allow the study to proceed but ask for certain additional information to be supplied within a certain timeframe (raising so-called "Non-Hold" issues)(most common outcome in my experience), or they can withhold permission to start because of larger concerns (thus placing the clinical trial "On Hold")(this occurs about 20% of the time in my experience). As NVIV submitted an IDE that has not been yet approved, they fall into the last category.
Issues that typically arise which result in an IDE being placed On Hold can range across a broad spectrum, but fall into one of the three areas of the IDE: manufacturing, preclinical tox or clinical trial. Again, in my experience, issues that would result in an extended Hold period (as NVIV has experienced) are generally related to either manufacturing or preclinical tox. For example, Geron, which has their IND (roughly equivalent to an IDE) on hold for a long period, needed to follow up some initial toxicology findings with an extended additional animal study (which they disclosed early in the process, by the way). A sponsor (NVIV in this case) can take as long as they want to address FDA concerns, but once the additional data is supplied to FDA, they have another 30 days to address and either allow the trial to proceed or keep it on hold if the new material still does not justify/address FDA concerns. That is the process, period.
Now the burning question: Why has NVIV's study been on hold for so long? First off, "FDA feet dragging" which has been posted as the explanation by many people here is clearly wrong. "FDA inspection of the new facility", which has again been posted by some here is also wrong as FDA DOES NOT inspect manufacturing facilities this early in the process. If someone at NVIV is giving this reason to investors over the phone they are lying as well as making a privileged disclosure. My guess is FDA does not feel that the preclinical data does not support the clinical trial design, basically meaning that what they've done in animals is not adequate, either in procedure or results, to justify going into humans and have asked for more data. Without going into detail, I can say that taking a combative approach with the FDA is never the way to go, and threatening them is in fact menacing of a federal employee.
Whatever the reason for the delay, it is the duty of NVIV to disclosure the nature of the delay as well as the steps being taken to remedy the issue and a realistic timeline for doing so. The management at NVIV is negligent and I would press them for full disclosure. Best, D.
Darren, nice to see you back on the board.....like you, I come to check-in from time to time to see if anything has changed. As you can see, nothing much has changed. They recently halted the slide of the stock-which by my reckoning began not long after the grand debate earlier this year-by issuing a press release that said "FDA ruling likely in Q1 2013." What a great press release! Anyhow, the stock rallied and has since bumped to the $1.60-1.80 range.....while management remains as dubious as ever....and the "science" behind it all remains as unshakable to the stalwarts as ever........so, good to see you back......please keep providing your thoughts as you're able.....I'd love to see NVIV succeed for the greater good....but ever since that last round of discussions (thanks largely to you) I lost all faith I had in the management.
Stock was 2.36 when this guy started posting here on April 25. It subsequently spent nearly 2 months well above that price (July and most of Aug.). He had no affect on the share price, despite his best efforts and the overly-emotional "grand debate." Sorry to anyone who loves this forum, but that just shows you how very little impact a stock message board has. Springer's Seeking Alpha story is, well, another story...
violate his confidence? what a joke.
"my guess is fda does not feel that the preclinical data does not support the clinical trial design, basically meaning that what they've done in animals is not adequate, either in procedure or results . . . " i'm not telling you how to bash, but my guess is you meant to say the fda actually "feels" that the preclinical data does not support the clinical trial design. we all know your agenda here, you hate reynolds. and when you're not protecting the innocent investors here, you are bashing reynolds, sometimes personally. it seems kind of juvenile, but it's a free country, so bash all you want.
but what's really funny is that you seem to think that curing spinal cord injuries should be so easy that the fact invivo has had setbacks and delays ultimately means it must be some sort of ponzi scheme. either that or you have a problem with anyone helping sci patients live a life outside of a wheel chair.
and now you are accusing nviv of threatening the fda? i haven't read such jibberish since joe springer's article a few months ago. i look forward to your next article, joe
I'm in the stem cell biz and have spent time in almost every bigpharm/bio and academic university in the greater Boston area. I've seen my fair share of exciting technology firsthand and NVIV blew me away. Stay long folks
Sentiment: Strong Buy
I think that when they filed for the FDA approval, they were not ready yet, they have only just opened their new cleanroom for cGMP manufacturing of all hydrogels and scaffolds. They said that once they have manufactured the first batch in the new facility, that they will provide the information to the FDA. So they are saying basically that they need to manufacture the scaffold in the new room first, before they can get the green light from the FDA.
Unless they are lying to us...I think that we can expect FDA approval a month after they manufacture and test their first batch.
If they are not disclosing important information tho...I would be pretty #$%$.
Sentiment: Strong Buy
Opening a new headquarters with in-house 3D manufacturing equipment that needs to be installed and calibrated, staff hired and trained then a series of test batches run and confirmed for quality takes time, including generating the data and formatting it for the FDA.
Caution at this time is very important since any material they provide for FDA approval had better be dead on or its rejection by the FDA will be a huge setback for the companies credibility.
I'm ok with the explaination by Frank Reynolds on this issue, however in the past NVIV has made estimates of time to important goals that have proven to be overly optimistic. Either they were naive and FDA requirements were more demanding than they expected or they fudged the truth to keep investors interested.
I don't think the FDA has been the hold up either... Agree they probably asked for more data and that takes time to gather. Yes... The way disclosure has been handled has been #$%$ poor too.
I am a buyer but this is a risky play.
Fair enough, except you have less information than does the company itself. They have identified Q1 as a likely time frame. The fact that they ARE imminently testing materials from manufacturing indicates that they are NOT as early as you think they are in the process. Everybody is entitled to their own opinion, but as outsiders we don't know and can only trust in the company updates.
Pem: Where have they disclosed that they are/will be testing materials? What sort of tests? I have not seen anything publicly disclosed. I'm not saying that they are early in the process; the fact that they have been on hold for almost a year and a half speaks for itself; they clearly were not prepared when they filed the IDE. D.