What's the downside? This company has added a lot of interviews of the scientist and board members running this company to its website. Very impressed. How can you not be? MIT? Stanford? I always look at who is running a company before I invest and I am so impressed and humbled. Check it out for yourself. Any one of us could be in a car accident today, be paralized, and this amazing technology will not be available. How devastating.
Hopefully, the FDA will approve this as soon as they can because there are so few options. They reversed paralysis in monkeys in 5 weeks! If it works, the studies on humans will be a success and it will be evident right away, not in years. They shouldn't have to do year long studies on this since the effects are either there or they are not.
This company and the people running it are the good guys. I hope all the little investors like me can sleep at night finally with a great investment. Not good. GREAT!
Awesome presentation. Anyone interested needs to listen to full presentation then make their decision to buy or not. I dont see how anyone could not want nviv stock after hearing this. Every base is covered. Thanks for posting link everyone involved. Steve
Frank starts talking on that presentation (6/20) at the 4:55 mark so you can move ahead to that point ... Nobody on the planet has more to say and can say it quicker in a presentation than Frank, so use the pause button a lot to stop and think about what he is saying.
Frank Reynolds said on the last couple of presentations said that the Phase I trial soon commence will have 5 patients instead of the originally planned 10. Apparently FDA has decided issue of safety can be demonstrated with just 5.
Reynolds also intimated that if 5 patients show consistant good results FDA may permit them to proceed to market without a formal Phase II, III.
Orphan status, medical device built on already approved materials appears to give them quite an advantage.
Frank says he thinks they could be to market by end of next year. Every president of companies facing the FDA are optimistic and usually disappointed but in this case with great Phase I results he may not be.
To all the new people here, the human trial will also be two-phase. The entire trial is planned for 10 patients. Phase I will involve only 2 patients. If their progress meets expectations, they will roll in Phase II (the remaining 8 patients).
Speaking of ONCS, that's one I will definitely be adding to my portfolio once I have enough profits and additional investment funds to buy as much as I plan to.
I'm a complete newb when it comes to this stuff but I had a question/observation that maybe someone could clear up for me. Frank said at the end of the video that the walking monkey was treated with stem cells. Is that stem cell treatment included with the trials they're waiting for approval on? I would think that using stem cells would take much more to get approved than the medical scaffold. If the stem cell treatment is not included it would seem logical that we won't see the same dramatic results. With that being said isn't it kind of misleading that they're parading these videos of walking monkeys for treatment that, at this time, they are not currently getting approval for? Am I wrong about all this?
In the monkey trials they got progressively better results starting with scaffold alone, then hydrogell with methlprednisolone then scaffold with cells.
Scaffold alone was good enough to be a blockbuster and fastest path through FDA.
as i understand it, it's a two step approval process. The scaffolding eliminates further damage and is being reviewed 1st, then the combination comes right behind it. As he said, there are various treatments combined with scaffolding depending on the injury. Someone else may can elaborate better on this.