This is a nice little rally that NVIV has manufactured today through the press release. If they could actually manufacture and sell scaffolds and hydrogels the way that they manufacture press releases then this company would truly be amazing. Indeed, perhaps it will be someday soon. However, I still can't bring myself (I'm sure you will all be distressed to hear!) to buy into this pseudo-news. I can't see how this is any different from the well-established pattern of using press-releases, promises and small time promotional tours to keep the tremendous earth-shattering buzz alive-when in fact they haven't even begun a trial. But the obvious (and by no means only) reply is "conversations" with the FDA, "medical device exemption," and "once this thing gets going" you will be left far behind in an instant. Does anyone else find it more than coincidental that this press-release, whose title seems to me dangerously (and intentionally) close to violating "safe harbor" guidelines, shows up at precisely the moment when some of us have started to raise and revisit old questions? Perhaps that is the way it should be....management responding to shareholder needs. But isn't this fundamentally the same thing that we were hearing back in April, when it was, 30, 60, 90 days? Is there anything that has really changed? Has Frank Reynolds or anyone else really given an adequate explanation for why this is taking so long when we were being led to believe six-months ago that it was imminent?
I remember when Ed Werth came to NVIV it was another big "news" event that helped to propel the upward momentum. But now he is gone and "factman" shows up on the board out of nowhere talking about how "Werth" is a "stem-cell" guy and not a "good fit" and the new guy is great, and the FDA ruling is being delayed because of the need to analyze the new (and improved) materials being produced at the new facility. I'm sorry, but it just seems like the same pattern of cleverly using "news" to keep people abuzz about how this thing is going to skyrocket and you better get in now. And almost everyone seems to be buying into this mentality without asking many questions.....although Pemmanuel and others (to their credit) have talked openly about the "amateurism" displayed in many decisions. For me the combination of "amateurism" + "development stage bio-tech" is a pretty shaky one at best....a poster replied to me the other saying that "he liked to gamble".....indeed....these companies are inherently high-risk.....so I think that you have to grade management very strictly.....today it is obvious the class is giving management a very strong grade with their dollars....not me.....I still see "bread and circuses" instead of any real substantive change....and maybe that will change.....I will keep watching.
It sounds like you're uncomfortable with biotechs at this stage of their development cycle. That's fine. There are some of those that are and they will invest here. There will be others, like yourself, that are uncomfortable investing at this stage and that is also fine.
No, I'm not comfortable with the overall performance of NVIV's management thus far, and in my opinion development stage pharmas demand management as great as the science....the main arguments that I hear are for the science of NVIV....and that could very well prove to be true. But the lack of great execution from the management (IMO) is what concerns me and raises questions. By far my biggest investment at the moment is in a development stage pharma that has been cleared for Phase II and is doing a financing that will hopefully result in a NASDAQ listing very soon. To this point I think that the management team has been exemplary and on task, and they only speak when they have something that is materially relevant to the forward progress of the company. Furthermore, the salary of the CEO is about 1/3 of Frank Reynolds' even though he is much better qualified and doing a much better job leading the company. IMO their capital structure has been tight and efficient, and the business plan consistently on track. Perfect? A guaranteed success? Definitely not, and still subject to the same kinds of swings indicative of the sector...but in my opinion just run much better and smarter than NVIV and has the same very lofty long-term potential.....so, I took my money out of NVIV and added it to my other position......simple....but I'm still in the same space there that you are here in terms of the sector and the inherent challenges....my concern is not with these types of companies, but instead with how they're being run in the office as well as the laboratory....for maximum return (and in most cases any return) you need excellence in both of those areas.
What I found most valuable about Frank's note to shareholders was that the FDA has not asked for additional data to support the application but is instead waiting for NVIV to produce a batch of scaffold in their brand new manufacturing facility that the FDA will accept meeting GMP standards.
Since the folks at NVIV virtually invented the field of biomaterials I see no reason to doubt they will accomplish that.
However I assume that Frank knew four months ago this requirement would take time since opening their new facility had a schedule to it that would include installation of manufacturing equipment and then time to get it all up an running and so speaking in terms of having the trial under way by Q4 should have been obviously impossible to him.
Couldn't agree more. Saw the headline "Invivo Therapeutics sees FDA approval to start clinical study" on my phone along with a 28% increase in value this morning, and got all excited and was like "FINALLY". Then I actually read the letter to shareholders (a separate PR), and was a bit let down. I didn't really see anything new or different in there, that wasn't already known yesterday. Will be looking for confirmation that this rally has legs, and isn't just the result of a suspect headline and huge early move up before I add anything here.. I do appreciate they are communicating with the shareholders, but something definitely feels a bit off and since I don't know what's going on I'll protect my principle and wait (so maybe I only get a 100% return instead of a 300% return.. I'm ok with that so long as it means I'm not risking the potential of an 80% loss in principle... which has happened to me with early unlisted biotech before).
if you're not short and not long, why are you here? Why would anyone dispute the news release because of the garbage you are spewing? The pps just dropped from over $2.50 to 1.26 in a matter of a few weeks, so any responsible CEO would do the same and re-assure shareholders as he did. I appreciated the update and obviously many others did also.
Sentiment: Strong Buy
As I've made clear in earlier posts, I was in NVIV but decided to sell my position, but continue to watch the company and maintain interest in its development.....if you review my posts/responses you will see that though I'm critical of the company I'm not deliberately trying to attack or subvert it....and I'm definitely not short and have no intentions in that domain. I don't need an actual position to participate in these discussions.....I'm participating because I maintain an interest in the company, but have not seen things that I consider red flags resolved.....sharing my opinions with others and hearing their feedback is part of my ongoing due-diligence and assessment process....that is one of the benefits of forums like this one....the only cost is time and perhaps some ruffled feathers as people debate....I think that there are more than enough bulls here on the board....no problem there....I'm obviously bearish at the moment, but I'm not sharing to try to take some kind of high-ground or make a point....as I said, I have an interest in the company that may in the right circumstances lead me to once again invest.....and dropping into this forum from time to time to share opinions and engage is part of my broader discipline....and honestly, I enjoy conversing and trying to figure out these puzzles with others.....if you don't like or appreciate my perspective, that's fine....ignore the posts or put me on ignore.
You're absolutely right, I'm distressed to hear you won't be buying shares. Thank you for sharing the information though. I wouldn't have been able to sleep tonight wondering what you were going to do.