Sometimes Georgie talks about his nephew. So he must be like Uncle Ernie.
Georgie can you hear me. Can you feel me near you.
Who is Georgie Georgie Georgie Georgie?
He's a pocket pool wizard there has to be a twist. A pocket pool wizard's got such a supple wrist.
I think all the most recent updates have more than confirmed that this has absolutely zero zilch nada to do with the two inadvertent deaths of badly injured patients. A control arm wouldn't have anything to do with safety and there is no safety factor in question. They are currently at 100% on safety. A control would have to do with the efficacy component.
Ok, so let's speculate on how there can be a reasonably well executed control arm should that be come an absolute requirement. [Before that, I just have to say that for a probable benefit study, it really shouldn't be necessary with this kind of procedure]
Would the surgeon tell the patient that they will either be NSS implanted or "drained and irrigated" each of which *may* deliver a better prognosis than doing neither? And also, how large would a control arm need to be in proportion to the full 20 patient enrollment in the INSPIRE HDE study? Ten patients? Perhaps there will be a surge of participants and this wouldn't be much more of a delay id enacted? I also wonder why the FDA would go back on their original word especially since this study is proceeding with 100% safety success (their largest concern) and is vastly exceeding the success rate proscribed. This smells of some potential competitor influencing the FDA to put up a stumbling block.
While a drainage and irrigation might reduce the pressure and clean the wound, without a scaffold there would be no:
- Appositional healing substrate
- Support structure for a spinal cord having altered morphology (bend, crimped)
- Substrate by which nascent cells can attach to
- Scaffold to which stem cells can be seeded in the future
I think it is shameful that the FDA would potentially go back on its word and require (or even suggest) something that can further delay this improvement to medicine.
InVivo has added two clinical sites recently, and with all the sites back online, could get a swarm of new patients and I expect those patients to continue to conform to the overwhelmingly successful conversion rate currently seen. Meanwhile, they increase exposure to the clinical world via their participation in prominent events.
The right ingredients to move NVIV out of "sleeper" status and back to popularity and influx of more investors as it gets closer and closer to completion of INSPIRE and HDE submission.
We're not gonna take you, never did and never will.
Don't want all your trolling, and as far as we can tell
We're not gonna take you, we foresake you, gonna hate you; let's forget you better still.
CEO: "We believe Alzheimer’s is a chronic neurodegenerative disease directly correlating with age, and it is similar in that way to Parkinson’s and other chronic dementia diseases. On the other hand when you have a genetic predisposition where the cells are constantly stressed or proteins are misfolded, or out of homeostasis, the body’s own repair system is probably over-challenged, overburdened, but with small molecules, you can increase the expression of the sigma-1 receptor, potentially restoring homeostasis and potentially reducing those dysfunctions. The difference would be the positive features mentioned before; we are seeing a reduction in amyloid beta but also in tau and inflammation. Calcium balance is restored and oxidative stress and mitochondrial dysfunction are improved. So our approach is not one hypothesis-dependent approach. It is utilizing a more comprehensive approach. It is more macro-management of disease rather than a micro-management approach to the disease stage. So, we are basically in sync with any hypothesis because the sigma-1 receptor is reacting independently to whatever form of dysfunction is caused by the disease."
What an idiot. This stock is not chart driven, it is driven by catalysts and fundamental achievements related to its pipeline. All of which look QUITE PROMISING from here through year end.
So if we get a price dip today, it would be bonus gravy. But even if we uptick today I plan to add shares. And the reason is that we could get some updates next week on Monday or Tuesday, whatever. There are a number of things going on and we're in a time period between now and December where it is highly likely that there will be share appreciation.
Anybody know why?
How does one statement have anything to do with the other? Apples and cucumbers.
If InVivo was for sale, when considering the future value of the pipeline, all the IP and licensing and potential revenues, the company is worth at least $540M market cap. Now go back and read that tortuously confused comment from wildfire on SCI.
Hey, finally something in Boston.
Well, it is sad because it shouldn't have come to that. He should have had more common sense than that of an animal cracker and he should have communicated this important information earlier. Early and often, Perrin. Remember that clique. Sometimes you're your own worst enemy.
Nice jumping to a conclusion here. Maybe the red thumbs are from investors here who have been following this company for 5 years and know more than you do and reject your hypothesis. I didn't want to insult a "nercomer" (if you are one) and tell you that your original post comment indicates your lack of understanding on this study.
There have been no indications from anything ever disclosed that they would be sifting through 500 SCI cases to cherry pick anything. The fact is that the inclusion/exclusion criteria is very stringent and was approved by the FDA as such for safety concerns. In my opinion it is too restrictive but that's what you get when you deal with regulators.
You made a very awkward comment, "May be this will work only if the damage has a particular structure (within the definition of incomplete SCI)," which speaks of considerable ignorance on your part. It isn't even worded clearly, but I'm not going to play English teacher on this board. And, FYI, they are not even working with INcomplete SCi patients in this study.
In my opinion, you need to do an extensive remedial DD on this and yes, you diserved those red thumbs on the basis that I just put forth.
What do they tell a prospective "control" patient? "We are going to cut into your dura and release the necrotic fluid and rinse the wound and re-stitch you up which carries little risk but may help your healing process?"
I's one thing to have a control arm for mice and monkeys and how do you get a HUMAN patient to agree to it?