Timing and the investment case for Mesoblast "Nothing in life is to be feared, it is only to be understood. Now is the time to understand more, so that we may fear less." ( Marie Curie)
Missing Primary Endpoints There are posters who have attacked SI and the team for the missing of Primary Endpoints..... If only Novartis was involved, with their expertise we would know how to design a trial and we would be home and dry, is an argument I have picked up on across the threads. Some have waged it seems a campaign on this matter. Yet "knock me down with a Kodpiece" a whole slew of posts and press coverage on the fact that Novartis are fallible.
Novartis heart drug fails trial, curbing growth prospects - JULY 29, 2019 Novartis’s heart failure drug Entresto failed a trial in a new use, the Swiss drugmaker said on Monday, calling into question billions of dollars in potential revenue and taking the shine off one of the company’s biggest growth prospects......The trial narrowly missed statistical significance for its composite primary endpoint of reducing cardiovascular death and total heart failure hospitalizations,” Novartis said.
Sorry, stupid me, just realised that this failure was in 2019, so not the one recently referred to.
How about this one?
Biotech Novartis' asthma drug fails in phase 3, raising doubts about Gossamer's prospects - Oct 22, 2019 Novartis’ asthma prospect fevipiprant has failed to improve lung function in two phase 3 trials. The negative top-line data deal a big blow to the prospects of a drug analysts tipped to achieve blockbuster sales if it cleared phase 3.
Ahhh! 2019 again, (not a great year for them it seems), all that work all that money down the drain. Can you imagine if @pickoneofmany had been a shareholder there instead of at Mesoblast? The posts on their forum, my goodness!
So what about this one. Novartis misses in melanoma, but maybe not by much.....Failure of the Combi-I trial in melanoma wrecks spartalizumab’s route to market, making Novartis’s anti-PD-1 latecomer even tardier.Trial Results. The Combi-I trial, which used Novartis’s unapproved PD-1 agent spartalizumab on top of Tafinlar and Mekinist, did not meet its primary endpoint, the company quietly announced late last Friday. This was supposed to be spartalizumab’s route to market so this is clearly disappointing; however, a closer look at the Roche data in this setting suggests that the Novartis trial might not have missed by much.
Whoops sorry that story was in August 24, 2020. So not the current one. However yet another missing Primary Endpoint but not by much! But it was their route to market that was wrecked. But guess what, looking at the data????
Well it appears that it did not miss by much so still a possibility. I wonder if you have read this far in this post, might you be thinking as I was, they seem to be a lot kinder to them, than they were with Mesoblast when we missed a recent primary endpoint? and we had data you could build a $100B company on.
Let's crack on, how about this one?
Novartis: Phase III CANOPY-2 Trial Of Canakinumab Fails To Meet Primary Endpoint - MAR 9, 2021 Novartis AG (NVS) Tuesday announced that the Phase III CANOPY-2 study evaluating canakinumab (ACZ885), an inhibitor of interleukin-1beta (IL-1ß), in combination with the chemotherapy agent docetaxel, did not meet its primary endpoint of overall survival.
Is that the drug that these posts on the forum have been referring to? At least it is this year and it primary endpoint was missed?
Ok this is my last effort to find out some relevant trial from Novartis which is going to support the "leave it to the experts SI, theory", you know the one, "we cannot do it without you", try this on for size.
Amid impressive growth, Novartis' blockbuster Entresto falls short in post-heart attack trial - Apr 27, 2021 12:14pm Novartis is banking on a broader label to expand the reach of its blockbuster heart med Entresto, but in patients who've suffered prior heart attacks, the drug just hit a setback.In the phase 3 Paradise-MI trial, Entresto missed its primary endpoint to reduce the risk of cardiovascular death and heart failure after an acute myocardial infarction, Novartis quietly revealed in its first-quarter earnings statement
Now I have said it many times, I am a "hole driller", my investment in Mesoblast was in an area I knew nothing about until I started looking at Mesoblast after talking to an investor. So my arguments will not be watertight, they are there to trigger a bit of debate and hopefully some considered comments from other more informed posters. But to the layperson, I am sure that this Entresto in April 2021 must be yet another Family member of the Entresto family that failed its primary endpoint for another condition it 2019. Luckily it seems that one member of the family, is keeping the wolf from the door.-
Entresto sales US $ 2,497m (that is nearly $2.5 Billion) up apparently 45%,
Let's hope that the side effects don't cause it litigation issues down the road. Perhaps those "Chumps" threatening us, might turn their attention there. low blood pressure (hypotension) ,high blood potassium (hyperkalemia), cough, dizziness, kidney (renal) failure.
This is not a post knocking Novartis, far from it. They are one of the worlds most successful pharma companies. It is just to point out that missing primary endpoints is not unusual and not the end of the road. We have a world class team, Novartis can enhance that for sure. But they also need successful new treatments to fill voids from the failure of others and the patent expiry of the successful ones.
We have established that "Rem-l and Rex-L do no harm. The data has shown where they work, and we have a better idea of how. We know that all of us don't we?
We know that Novartis have been spending about $8 to $9 billion a year of R&D yet seem unable to increase their turnover. We also know that they are used to missing PE and that a block buster can make up for many failures. It is just a case of understanding. Which brings me back to Marie Curie.
We understand , we have nothing to fear, we have a fantastic case for investing in Mesoblast, with a share price to "buy for".
May or June? that is THE question, I am waiting to be answered. Not if, but how much. Regards Yelrom
(20min delay)