Furthermore, the real "kicker" with this drug, for this indication, is that MSB has exclusive commercial rights to this product for the world (ex-Japan).For MSB, this FDA decision is a BIG deal.Thanks for the contribution, but for the one thousandths time.....It's NOT a drug!
Also ARDS for Covid-19 is far from the only application. Instead your focus is on aGVHD.
You're a medical professional ....and the implications
drug vs stem cell therapy aren't fully filtering down in your terminology.
More importantly it shows the RISKS are being misconstrued and misunderstood by the average investor.
Your conclusion shows an understanding that Ryoncil is unique. Indeed it is.
I'd go further than you and say that the first therapy of choice re aGVHD, will not be steroids, in terms of clinical practice, but remestemcell-L/Ryoncil. That's inevitable because of the effectiveness, and because the MSCs calm the immune system and rebuild it. As well as rebuilding the target cells. Steroids weaken; they're a retrograde step when you're faced with the superior option. It's such an achievement, for Ryoncil to make the aGVHD patients already weakened by steroids, mostly better. What if they weren't as weakened in the first place?
MSB has already proven in several studies that it works on even the most sick ARDS/Covid19 patients who've had their immune system exhausted/collapsed with a cytokine storm. The damage can be colossal, in some there is the need for a double lung transplant. That's extremely serious cellular damage.
Steroids as we know, flatten immune systems. They aren't a solution they're an extreme measure. They don't rebuild tissue. Japan has already approved Ryoncil for aGVHD it's a no-brainer to them.
Finally this is a revolution in medicine.
I don't detect the level of excitement that I should probably because of the overburden of standard terms of reference.
This article states that
Mesoblast is world leader in cellular medicines for inflammatory diseases.
https://www.globenewswire.com/news-release/2020/04/01/2009842/0/en/FDA-ACCEPTS-MESOBLAST-S-BIOLOGICS-LICENCE-APPLICATION-FOR-RYONCIL-AND-AGREES-TO-PRIORITY-REVIEW.htmlI'd suggest you take a close look at the previous studies on ARDS. One in China and one in the US at Mt Sinai Hospital.
They essentially inverted the survival rates again, for the sickest patients.
Let that sink in. I no longer care about what the market is doing. It's white noise to me.
(20min delay)