will either give approval or it won't. if it does, the stock will get another bounce. whether the bounce sticks and for how long, who knows. if it doesn't get approval, then its back to practicing on monkeys. my guess is it gets approval. even with approval, it's a long slog...investing in these types of companies takes lots of patience...and I'd certainly recommend a basket of speculative stocks so one will make up for the failures of the others.... my basket consists of LXRX, SGMO, VICL, PSDV, ISIS, KOOL, PSTI, & NVIV for better or worse.. and a few others outside realm of medical / medical device field....do your own DD......GLTA
My only disagreement is that I believe if... no when the FDA issues its approval, this will be the starting gate to success. The hurdles are minimal. Why? The procedure WORKS in monkeys, and has been proven SAFE in monkeys. The upcoming human trials are more about safety than efficacy. No complications = success. Obviously functional recovery = success as well. Greater success. And the threshold is quite low. The company has been saying for months, "if we can spare just 10 percent..." Does everybody realize what this means? The monkey studies were overwhelmingly successful and the human trials have this very low bar on efficacy. There is good reason for this lower bar to be in place because the monkey injuries were surgical and not traumatic. Still, ANY functional improvement in humans will be huge. Safety is pretty much a given since the material has been used in sutures for many years.
So, we get a sizable step up just from FDA approval. It will sustain because shortly thereafter will be the news of human trials commencing. Then it goes up again. However, once trials begin, after peaking we could see a little pullback as some may hedge slightly in case of less than expected results. HOWEVER, if results are excellent, this goes to the stratosphere. Why?? Well, as a medical device company, the pathway is shorter and easier than drug from a pharma! And the HUD/HDE pathway makes that clear. They would be able to move into small revenue generation quickly. From there, as additional safety and efficacy data are collected, the FDA upgrades its approval beyond HDE and once in full scale market, InVivo Therapeutics gets to play in the $10 Billion acute SCI market.
By this time, the hydrogel formulations will be ready to come to market in both CNS and Peripheral indications. The peripheral market was estimated at $20 Billion. Then comes the chronic SCI market by the time the scaffold and/or hydrogel with stem cells is approved. Happy New Year 2018.
(Can you believe there were some skeptics back in 2012?!)
Hey kool, if fda gives the approval we are looking at putting a custom made patch into the spine area of 5 patients. Its either going to work or it isn't. If it works we should know within a couple months of the first patient being treated. If any of the 5 patients gets better it works at least 20% of the time. If all 5 get better it works 100% of the time. Its not like drug trials that take a few years to complete. The scaffold is either going to allow reconnection of signals or its not. Just my speculation but i dont think this is going to drag out like all the other regenerative medicine companies im watching are. By the way i see your into some pretty neat companies but i didn't see actc listed. You might want to check them out if you haven't already. Im only in gern,nviv,actc, and cur. All are long term holds cause im in this till major inflection points are reached. If i had more money to spread arround id get into psti but i dont know much about the others. Steve