|
Post by CardsFan on Aug 17, 2020 12:17:18 GMT -5
|
|
|
MESO
Oct 5, 2020 20:53:30 GMT -5
Post by halmorris on Oct 5, 2020 20:53:30 GMT -5
Thanks
|
|
|
MESO
Oct 5, 2020 20:59:53 GMT -5
via mobile
Post by Blitz on Oct 5, 2020 20:59:53 GMT -5
It appears to have hit a snag based upon the stock’s recent drop.
That could be good for new buyers if it’s just the market misinterpreting data?
|
|
|
MESO
Oct 6, 2020 0:11:46 GMT -5
Post by CardsFan on Oct 6, 2020 0:11:46 GMT -5
It appears to have hit a snag based upon the stock’s recent drop. That could be good for new buyers if it’s just the market misinterpreting data? The recent drop has to do with FDA doing something I’ve never heard of. Its subcommittee, at Adcom conference, recommended approving GVRD product 9-1. That always means it gets passed by FDA. This time, it didn’t happen. FDA asked for a fourth trial. That’s unheard of given FDA is one who set parameters of last phase trial. Now they are moving goal posts, despite MESO meeting endpoints. Company is appealing decision so we shall see. they know the product works. They are arguing about trial design. MESO did a single arm trial, instead of double blind, for pediatric gvrd because no other product works, and since these kids are already resistant to steroids before they even get to point of needing product, requiring a placebo is dooming kids to almost certain death. read the Adcom trial notes. They know it works. They know it’s safe. That usually all that matters. Since stem cells are a new thing, lots of folks are hesitant to approve them because they just don’t understand ‘how’ they work. That’s the short version. they have regular double blind trials for multiple other indications due next two months or so. Lower back pain, heart procedure, and also COVID. The recent FDA setback is always a risk, but I want to believe in humanity, given product has been proven safe. My take is, I don’t need them to pass most trials. As long as they pass 2 or more, the stock should run. that being said, everyone should do their own due diligence. I wouldn’t be shocked if drug companies are paying FDA to stonewall stem cells given drug cos will lost billions if SC’s ever go mainstream
|
|
|
MESO
Nov 13, 2020 0:46:30 GMT -5
Post by CardsFan on Nov 13, 2020 0:46:30 GMT -5
Update. MESO just got COVID trial extension which was positive. In the next few weeks, we should also start getting major news on whether their chronic heart failure and lower back pain products passed Phase 3 testing. American Heart Associations annual conference is next week so should get first update then
|
|
|
MESO
Nov 19, 2020 23:22:37 GMT -5
Post by CardsFan on Nov 19, 2020 23:22:37 GMT -5
MESO just got a huge partnership deal with Novartis. Guys should really look at science behind their trials. It’s amazing stuff. As always, due your own due diligence
|
|
|
MESO
Nov 20, 2020 7:05:21 GMT -5
Post by Blitz on Nov 20, 2020 7:05:21 GMT -5
Mesoblast inks deal with Novartis to develop COVID-19/ARDS stem cell therapy, shares +17% Nov. 20, 2020 1:45 AM ETMesoblast Limited (MESO)By: Mamta Mayani, SA News Editor seekingalpha.com/news/3638221-mesoblast-inks-deal-novartis-to-develop-covidminus-19-ards-stem-cell-therapy-sharesplus-17Mesoblast (NASDAQ:MESO) surges 17% after entering into an exclusive worldwide license and collaboration agreement with Novartis (NYSE:NVS) for the development, manufacture and commercialization of Mesoblast’s remestemcel-L, with an initial focus to develop treatment for acute respiratory distress syndrome (ARDS), associated with COVID-19. Novartis will make a $50M upfront payment including $25M in equity. From the initiation of a Phase 3 trial in all-cause ARDS, Novartis will fully fund global clinical development for ARDS and other respiratory indications. Mesoblast may receive pre-commercialization milestone payments of $505M for ARDS indications, up to $750M in post-commercialization milestones and tiered double-digit royalties on product sales. Mesoblast will retain full rights and economics for remestemcel-L for graft versus host disease, and Novartis has an option to become the commercial distributor outside of Japan. For most non-respiratory indications, the parties may co-fund development and commercialization on a 50:50 profit-share basis. Mesoblast will be responsible for manufacturing and Novartis will purchase commercial product under agreed pricing terms. NVS will reimburse Mesoblast up to $50M on the achievement of certain milestones. Novartis intends to initiate a Phase 3 study in non-COVID-19-related ARDS after closing of the license agreement and successful completion of the study. On Nov. 11, Mesoblast gets recommendation to continue Covid-19 ARDS trial without any modifications. The stock has rallied ~95% over the past one year. While the Quant Rating is Neutral, Wall Street Analysts Rating is Very Bullish.
|
|
|
MESO
Nov 20, 2020 11:55:52 GMT -5
Post by CardsFan on Nov 20, 2020 11:55:52 GMT -5
Mesoblast inks deal with Novartis to develop COVID-19/ARDS stem cell therapy, shares +17% Nov. 20, 2020 1:45 AM ETMesoblast Limited (MESO)By: Mamta Mayani, SA News Editor seekingalpha.com/news/3638221-mesoblast-inks-deal-novartis-to-develop-covidminus-19-ards-stem-cell-therapy-sharesplus-17Mesoblast (NASDAQ:MESO) surges 17% after entering into an exclusive worldwide license and collaboration agreement with Novartis (NYSE:NVS) for the development, manufacture and commercialization of Mesoblast’s remestemcel-L, with an initial focus to develop treatment for acute respiratory distress syndrome (ARDS), associated with COVID-19. Novartis will make a $50M upfront payment including $25M in equity. From the initiation of a Phase 3 trial in all-cause ARDS, Novartis will fully fund global clinical development for ARDS and other respiratory indications. Mesoblast may receive pre-commercialization milestone payments of $505M for ARDS indications, up to $750M in post-commercialization milestones and tiered double-digit royalties on product sales. Mesoblast will retain full rights and economics for remestemcel-L for graft versus host disease, and Novartis has an option to become the commercial distributor outside of Japan. For most non-respiratory indications, the parties may co-fund development and commercialization on a 50:50 profit-share basis. Mesoblast will be responsible for manufacturing and Novartis will purchase commercial product under agreed pricing terms. NVS will reimburse Mesoblast up to $50M on the achievement of certain milestones. Novartis intends to initiate a Phase 3 study in non-COVID-19-related ARDS after closing of the license agreement and successful completion of the study. On Nov. 11, Mesoblast gets recommendation to continue Covid-19 ARDS trial without any modifications. The stock has rallied ~95% over the past one year. While the Quant Rating is Neutral, Wall Street Analysts Rating is Very Bullish. COVID stuff isn’t even a big deal. The big deal is their lower back pain, and chronic heart failure trials. If those hit, those are holy grail type treatments. ARDS for non COVID uses is huge is well, which is why Novartis got involved to begin with. When end I first invested I planned to either lose it all or knew it would be a huge winner. IF this pans out, and I admit it’s a huge if, it’ll be bigger than anything else I ever invested in. The terms of the Novartis deal at just tip of iceberg i rarely buy a rock once it’s gone up, but I actually added to my position at the open, when it was up 15%. It’s up 20 plus now, but it’s a small cap and not well known, so I think it’s still got a huge runway, at least until most analysts find out bout it
|
|
|
MESO
Dec 2, 2020 8:34:35 GMT -5
Post by CardsFan on Dec 2, 2020 8:34:35 GMT -5
FDA just gave MESO fast track status for COVID ARDS trial
|
|
|
MESO
Dec 15, 2020 8:21:42 GMT -5
Blitz likes this
Post by CardsFan on Dec 15, 2020 8:21:42 GMT -5
Did you guys see news on MESO latest trial for chronic heart failure? The article is misleading so I’d suggest listening to yesterdays conference call. Even if you don’t buy the stock, the 60% reduction in mortality for chronic heart failure, strokes and heart attacks are nothing short of phenomenal. This was actually the one trial, out of their many trials, that I was most concerned about.
|
|
|
MESO
Dec 15, 2020 23:39:40 GMT -5
Post by CardsFan on Dec 15, 2020 23:39:40 GMT -5
A trading halt was just announced. Last time this happened, was when Novartis partnered with MESO on ARDS trial. No idea why halt was issued this time, but I’m assuming that the recent cardiac announcement means another partnership or an outright buyout is in the works.
Good luck to anyone else who bought more yesterday. To be down 20% on the day, then up aftermarket was,definitely an emotional rollercoaster.
|
|
|
MESO
Dec 16, 2020 12:23:02 GMT -5
via mobile
Post by Blitz on Dec 16, 2020 12:23:02 GMT -5
Keith Speights (TMFFishBiz) Dec 15, 2020 at 12:56PM www.fool.com/investing/2020/12/15/why-mesoblast-stock-is-tanking-today/What happened Shares of Mesoblast Limited (NASDAQ:MESO) were tumbling 19.6% lower as of 12:41 p.m. EST on Tuesday. The big drop came after the company announced Monday evening that its off-the-shelf cell therapy candidate rexlemestrocel-L (Revascor) failed to meet the primary endpoint of a late-stage clinical study targeting the treatment of advanced chronic heart failure. So what Mesoblast said that Revascor didn't achieve any reduction in recurrent non-fatal decompensated heart-failure events. Decompensated heart failure occurs when structural changes in the heart cause obvious symptoms. The problem was that this reduction was the primary endpoint of the company's late-stage study
|
|
|
MESO
Dec 22, 2020 3:31:46 GMT -5
Post by CardsFan on Dec 22, 2020 3:31:46 GMT -5
Keith Speights (TMFFishBiz) Dec 15, 2020 at 12:56PM www.fool.com/investing/2020/12/15/why-mesoblast-stock-is-tanking-today/What happened Shares of Mesoblast Limited (NASDAQ:MESO) were tumbling 19.6% lower as of 12:41 p.m. EST on Tuesday. The big drop came after the company announced Monday evening that its off-the-shelf cell therapy candidate rexlemestrocel-L (Revascor) failed to meet the primary endpoint of a late-stage clinical study targeting the treatment of advanced chronic heart failure. So what Mesoblast said that Revascor didn't achieve any reduction in recurrent non-fatal decompensated heart-failure events. Decompensated heart failure occurs when structural changes in the heart cause obvious symptoms. The problem was that this reduction was the primary endpoint of the company's late-stage study This is one of the strangest scenarios I’ve ever seen. Looks like for second time in a row, the problem isn’t that the treatment isn’t safe, or doesn’t work. The bigger issue appears to be management being too aggressive with their primary endpoints. Or selecting the wring primary endpoints. Too much to type for time being, since there are four different trials in the works. most likely, fda requires several additional trials. But the mortality improvement (secondary endpoints) on the heart trial may be enough to get an approval. mortality is usually the primary endpoint. Since the data proves it works, I’m not sure if fda will care. We shall see
|
|