This is from @LeftYahoo - it's simply outstanding.
So, I'm just going to cut & paste.
Let me know if this bothers you @LeftYahoo - and I'll remove it 
A lot of the great discoveries in medicine start out with a “surprise”. Something happens that wasn't quite expected. Anonymous says: “Only buy if it reads "meets primary endpoints". Meso treatments are all the same. They help a little bit but not quite enough.
”I can certainly understand his point and sense the disappointment. The outcome in the CHF trial is NOT what was expected. I suspect the Company is also “surprised”. Inject stem cells directly into a failing muscle and what might we expect? Well, hopefully the muscle will regenerate or rejuvenate and get stronger. If it's a heart muscle maybe it will beat stronger to the point that activity level can be increased and medications stopped. We can tell that's what the company expected because... well it just sounds reasonable. And they set up a primary endpoint ready to document that effect. Like having a camera ready at the finish line. But that's not exactly what happened. We'll have to see the full data set when published, but it's looking like injected hearts don't beat all that much stronger. However... if you catch a failing heart early enough with an injection you can keep it from getting worse compared to an uninjected heart, and you can decrease the risk of death. So, that's good. And it makes sense. There's some remodeling... the muscle may not get stronger, but at least the progression to a weaker state is slowed. It adds up. A direct effect of the injection on the muscle. Perhaps not as strong as hoped for, but maybe it can be tweaked for a stronger effect with a second injection down the road. Not much of a surprise. The big surprise is something else. The “remote” effects of the injection. Inject the failing heart muscle and the patient has a lot fewer... strokes. A lot fewer heart attacks due to coronary artery blockage. Turns out the injection has an impact on the immune system to regulate inflammation elsewhere in the body. The company probably had those remote benefits in the back of its mind, but not as a primary effect and maybe not to the degree now being uncovered. The most statistically significant finding in the study was a “decrease in hospitalizations from non-fatal heart attacks or strokes”. Highly significant (p=.0002) across all causes of heart failure and across both NYHA classes of heart failure severity. Wow.
The FDA and the market may take their time to digest this, but a one-time injection giving that kind of benefit has the potential to become the new paradigm, the standard of care. You reach NYHA class 2 where symptoms begin to interfere with daily life and you go get your injection. A bit more complicated than getting a vaccine, yes, but somewhat the same concept: an injection into a muscle to modify the immune system with the idea of preventing serious problems down the road. With vaccines on our minds, we can all understand the concept.
It's not the first time this company has encountered a “surprise”, and I suspect there will be others before us. I won't be surprised by an ARDS “surprise” when the 60-day data set is released, hopefully this quarter. I believe there are reasons enrollment was stopped unrelated to the effectiveness of rem-L, but we shall see. I'm more hesitant to make any prediction on low back pain results. Other than to say, “wouldn't it be surprising if an injection of stem cells into the lower back led to a decrease in...”
No, that's beyond surprise into the realm of totally crazy. So, I'm not even going to say it. glta
(20min delay)