I have been an NVIV shareholder since it was a private placement long before it was a public company. I have been frustrated with Frank Reynolds longer than most of you. In talking to neurosurgeons who are familiar with this protocol it really does seem to be legitimate. The process has taken much longer than anyone thought or hoped. Part of this frustration results from Frank making bold predictions and stating arbitrary deadlines that are unrealistic which erodes his credibility time and time again. This is factual though: the HDE was filed, or at least the news was released by the company 12/14/12. (the HUD is a tag-along designation with the HDE, a stand alone HUD is a separate animal). I have triple checked this-the FDA has 75 days to respond to that submission. (A stand alone HUD by itself is a 45 day time frame which adds to the confusion here) A truly competent and attentive CEO should come out with a statement to that effect in response to today's price action. Message board hype, confusion and misinformation could be cleared up easily with an official statement regarding this matter.
Hi Hoozur, I haven't seen you post here before and what you are saying is interesting. I'd think most would normally apply for the HUD by itself first. It would have a lower threshold for gaining approval. I wish the December 14th press release would have accurately indicated a simultaneous HUD and HDE submittal if it is so.. I hope what you're saying about that is accurate. However it is a bit of a risky gamble for the company to approach it this way. Much of the input in support of HDE would ideally emerge after positive clinical trial results. If the trial is delayed, it jeopardizes the HDE approval. On the other hand, if the company is expecting the IDE approval very imminently, they may have enough time to treat a patient soon and supply preliminary the results inside of the 75 days. But wait: 75 - 45 = 30. They would have only 30 days left. It looks to be a careless strategy. But again we are all in the dark here. No verifiable facts, Very unfair.
Regarding frustrations... you mention that your frustrations with Frank go back to when it was a private placement. That's a bit disturbing as well. Yes, the old adage is you can't teach old dogs new tricks but how can FR not be cognizant of the harm that ensues from his modus operandi? You nailed it, "making bold statements...arbitrary deadlines...eroding credibility. For the life of me I cannot imagine why any CEO would continue to behave in this manner. It is a little bit akin to sabotaging one's own progress. And we have seen this happening! All those shares owned does impart a certain level of teflon, but I would think Fidelity, Mr. Stern and other mega investors would be issuing strong criticisms. Let's hope this extremely odd behavior finally stops. I can totally understand being stoked and enthused, but he needs to temper that with responsible communicating. The envelope is really be stretched on this.
Mr Reynolds saying January and the normal HUD 45 day rule got everyone in a frenzy today. Ask anyone about the hydrogel products and they say its amazing. Short term pops and drops will happen thank you for your knowledge. Nviv long
I think Frank was "hoping" it would happen this month but he needs to stick with cold hard facts which would help his credibility immensely. It looks like Feb 27th would be the FDA response deadline followed by 3 business days for NVIV to respond to any concerns. I am also running short on patience but the highly bureaucratic FDA seems to take it's time.