Fact 7: On Sep 18, 2012, Brain Hess replaced Edward Wirth as Chief Science Officer. Edward Wirth’ s expertise was in stem cell research while Mr. Hess basically invented the materials used in InVivo’s scaffolding devices. Getting stem cell applications in humans through the FDA can take several years. Mr. Hess was instrumental in developing HydroSetTM, an injectable calcium phosphate based bone substitute, from concept to product launch. The product has become the market-leading bone scaffold, and Stryker awarded Mr. Hess and his team with “Best Technology” and “Best Team Synergy” for their work on this critical product. Mr. Hess also won several research and development awards during his tenure at Stryker. Most notably he was named "Co-Innovator of the Year" in 2010 within Stryker Orthopedics. So their new Chief Science Officer is now much more aligned with the company’s goals.
Fact 8: On Sep 25, 2012, InVivo opened their new Office and Labs in Cambridge, MA. The polymer-based scaffold material will be made in this new state of the art facility. This will also act as the new company’s headquarters.
Fact 9: Approval from the FDA to start the 5 patient human clinical trials has been delayed due to the approval of batches made in in this brand new facility. These batches are to be used in the upcoming 5 patient human clinical trials. The approval is now expected in Q4 2012 with human clinical trials set to begin in early 2013.
When dealing with the FDA, it always takes longer than expected. Three to nine months from now this will turn out to be a positive as it has allowed new investors to buy shares at ridiculously low prices and allowed other investors who bought over $2.00 a share to average down.
Fact 10: InVivo has begun discussions with the FDA about its second product, a drug releasing hydrogel for use as a long term pain management of peripheral nerve pain. There are millions of peripheral nerve procedures performed on patients every year, and the Company will leverage its technology by also submitting its injectable hydrogel drug releasing product for use on peripheral nerve injury.
Fact 7-So, Werth is an expert in stem-cell research so we....moved in a different direction....Then why, if his expertise was in a fundamentally different area, did NVIV hire him in the first place? Wasn't it pretty obvious to everyone that the focus of his research at Geron was stem-cell research? Where was the due-diligence here? If the guy was a lab-assistant or junior-member of the research team it might be different....bring him in and see if he "fits"......but this guy was the Chief Science Officer of the company....and you're now telling us that you went in another direction because he was a stem-cell guy and this new guy is a better fit and much more "aligned with the company's goals".....Did they try to hire this guy before Werth? Does this provide us with any real information about why Werth really left the company and why they decided to go in a different direction? I think it sounds more like gloss and misdirection....this is one of the reasons why we're behind schedule......But everyone knows that being able to make great hires, especially in key positions, is absolutely fundamental to success in any business.....much less at a development stage company where wasting or failing to maximize small windows of time is huge.......the clock is always ticking.
Fact 8-Great, you opened a new facility that will also serve as a headquarters...killing two birds with one stone!....I wonder if it is more like killing shareholder value.....Did they really need to do that? What was wrong with the former set-up? Is it really a smart decision for a development stage company that has no real revenue and no product at market to being opening a new facility? Isn't this putting the cart a bit ahead of the horse? Like a team building a new stadium or facility before they've even been chartered by the league to be an actual team in the first place? In my view a very heavy burden of proof falls on management here to explain the necessity of this decision......citing this as a "fact" means nothing......it raises many more questions and answers nothing.....great, they accomplished something......but the whole project go to this point without this new facility-why now?....and what concessions in terms of pay and incentives is the management giving to the shareholders in lieu of the unsecured mortgage that is essentially being taken out against their equity in these moves?
Fact 9-Is this something that the FDA has officially said? Is this really a reason why the process if being drawn-out? My understanding is that this same approval was pending back in April when we were discussing it.....long before the opening of this new facility.....so, what happened betwixt then and now? If the approval was already pending back then based on materials already produced and ready for evaluation, why are you now saying the approval is now being delayed because of the need to vet materials made at the new facility? Was there some defect with the old materials that has been corrected, that needed to be corrected? What is the link between an approval pending nearly six-months ago and this new facility? I don't see the logic or the point here......again, it raises more question.....seems closer to an excuse than a clear explanation. And once again....."getting stem cells approved takes years with the FDA (then again, why did you hire Werth?)" and "When dealing with the FDA, it always takes longer than expected." Really? Isn't this kind of like a "tautology"-a logical obvious truth-for all of us......we all know that these things take a long time....it is pointless and close to an insult to all of us to invoke that....it is not informative! And we've already gone through one "3-9 months" period....but it is still just around the corner! Maybe it is.........but again.....is this a "fact" that means anything....No! It is an opinion based loosely on some information that doesn't really address the main issue.......and it is amateurish!
Fact 10-NVIV is in discussion with the FDA about another product........Great! But how is that a "fact" that has any material relevance to making money in the near future and putting these wonderful new facilities to profitable use? It doesn't mean anything....they're having discussions with the FDA about a new product and you adduce that as a "fact" to rebut perceived criticisms of the company.....perhaps you should go back to critical thinking class and refresh your memory about the difference between a "matter of fact" and a "matter of opinion".....NVIV either will or will not get the green light....that is a "matter of fact".....but right now all these things that we're discussing are just opinions about which way we believe things will go based on certain evidences (containing certain subsets of "facts," but still just "matters of opinion")......they will one day be proved right or wrong (and in that sense become factual)....but at present such things are not "facts" that matter to the immediate case at hand....a "fact" would be a press-release tomorrow green-lighting NVIV-or even saying approval was "imminent".....one that I really hope will come for all of you.....but none of these things that you've cited as "facts" does anything more than raise a lot of questions in my "OPINION!"