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Mesoblast Limited (MESO)

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6.51+1.04 (+19.01%)
At close: 04:00PM EST
6.55 +0.04 (+0.61%)
Pre-Market: 08:40AM EST
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  • E
    Ecoool Turtle
    Another great result for MESO published today.
    Forget Class 2 or Class 3 Heart Failure - Meso will end up treating diabetic and/or ischaemic patients with inflammation (CRP>2 or maybe other measures of inflammation in the future) and those patients will be treated regardless of whether they are in Class 2 or Class 3.
    That's a great benefit because Class 2 isn't a defined predictor of outcome and the definition is a little fluid. If they had gone with that definition another trial would've almost certainly been needed.

    Instead, Meso followed the FDA's guidance and went back and re-analysed the risk factors and identified the high risk groups, and these groups have reproducible high-risk, there's no doubt about that.

    Meso will now resubmit the data and may get approval without having to do another trial - under RMAT or breakthrough designation. We'll see if the new data is enough to get through the FDA's mental roadblock of the failed Primary Endpoint of reduced hospitalisations for decompensated heart failure.

    PS for all the people claiming that Meso didn't reduce hospitalisations in the heart trial, you are wrong! They clearly showed significantly reduced hospitalisations in non-fatal MI and Stroke in all patients - and these are very expensive hospitalisations (see 12 January presentation slide 26: Rexlemestrocel-L Significantly Reduced Hospitalization Rates from Non-Fatal MI or Stroke in All Patients, with Similar Effect Size in NYHA Class II and Class III Patients). They didn't get a benefit in hospitalisations for decompensated heart failure - which was a completely different EP - and which just measures people hospitalised for pump failure, volume overload, shortness of breath ie decompensated (or worsening) heart failure, where the control group and the MPC cell group had similar rates of hospitalisation due to the much improved standard of care for controlling heart failure. BUT THEY DID GET A BIG DROP IN HOSPITALISATIONS WHEN YOU LOOK AT HOSPITALISATIONS DUE TO MI AND STROKE (which are not measured as decompensated heart failure hospitalisations).

    In fact, in the whole trial of 537 patients, REX-L reduced hospitalisations in NF-MI and Stroke by 68% (p=0.0002) with a REX-L hospitalisation rate per 100 patient-years of followup at 1.9 vs Control group of a 5.95 rate. That's not the focus of today's analysis, but it is commonly misunderstood and its importance shouldn't be underestimated.

    We know that disease gets worse and inflammation increases as heart disease progresses. The diabetic and/or ischaemic patients were 72% of this trial - so whether they are in Class 2 or Class 3, eventually most of them will register high inflammatory markers. Meso's cells can either be used on them now if they have CRP>2 or later when their disease progresses, so this effectively expands the market to all diabetic and ischaemic heart failure sufferers as they progress in their disease (regardless of their current class of heart failure) - the CRP marker just indicates when the REX-L treatment can start - most of them will eventually get to that point of inflammation, and that means the potential market is over 70% of Class 2 and Class 3 sufferers according to the proportion of diabetic/ischaemic patients in this trial.

    The strong suggestion by MESO in today's announcement that the FDA confirmed that reduction in cardiovascular mortality or irreversible morbidity (non-fatal heart attack or stroke) is an acceptable clinically meaningful endpoint for determining the treatment benefit of rexlemestrocel-L for patients with HFrEF - means the FDA could accept these results even though the Primary Endpoint was not met.

    Meso also said that the FDA has previously accepted 3-point MACE reductions of 12-14% for approval of multiple pharmaceutical industry drugs to reduce cardiovascular risk in diabetic patients. The Meso trial reduced 3-point MACE by a whopping 54% in these patients with systemic inflammation (elevated baseline hs-CRP) - so Meso clearly thinks FDA is a good chance of approving REX-L based on historic precedent - but would they need another trial?

    Well, Meso also said that a single study to provide substantial evidence to support a BLA is limited to trials showing meaningful effects on mortality and irreversible morbidity (as this trial did) where a second trial would be practically or ethically impossible. So, there's our potential pathway to approval without another trial. It may be too much to hope for given the FDA's previous intrasigence when it comes to approving Meso's stem cell products, but since a second trial was assumed before today and given that none of this has been priced into the market, this is a highly significant announcement .in terms of Mesoblast's valuation. Today's announcement potentially brings the cash flows forward by a couple of years and reduces the uncertainty for the heart indication, so the discounting rates involved should be much less.

    A big win for MESO!
  • s
    shel
    Thanks for very informative post. Other aspects NOT to miss are the strong relationships of heart disease, stroke and diabetes to the development of Alzheimer’s and other neurodegenerative disorders, including those with one or more APOE4(13percent of US population, I think). Without too much work, one could estimate the decline in risk for AD, the number of years onset postponed, and perhaps even the slower rate of cognitive decline by reducing the number of heart attacks and strokes, especially in people with DM; and, the resulting life long improvements in quality of life and health care savings would both be staggering
  • L
    LongStock
    You can't get those 600% wins like all thos guru's claim they've had in the past, unless you recognize a multi-billion-dollar stock early. If you want 600% gains you got to take some risks and not be a crybaby everytime a dip comes along...that's going to happen from time to time.

    Investors here understand the risks and the potential. Two billion-dollar partnerships are on the table, one for ARDS and one for CHF heart indications and both are imminent. Two FDA approvals are also very close at hand, GvHD and ARDS.

    Yes, it's just talk but the facts about these opportunities all readily available and easy to find. This makes decision making a lot easier.
  • t
    tim
    I tried to post this a couple of times over the weekend but it kept getting deleted…

    It’s from the chairman’s address and refers to the disappointing knock back by the FDA regarding the gvhd for kids ..… “ However, we have regrouped and, after addressing the outstanding items that the FDA requested, we are confident that our collegial collaboration could lead to a resubmission of our current Biologic License Application”

    Mesoblast believes it has addressed the outstanding issue and that it is working closely with the FDA.

    Can’t wait to hear from the FDA… they will have to be very specific if they require further work. It’s time for an approval 😀👍
  • W
    Wilba32
    I found the mute button!!!!
    Bye Jeffy & Groupzero!
  • d
    didja
    the most aggravating thing abut this is that if any other drug showed this kind of result the share price would be 10 times this price but since this result is from the mysterious magic of stem cells that the fda hates we can't even get a dollar out of it.
  • M
    Michael
    Talk is nice, but it won’t carry us across the finish line. We have suffered another complete year of talk as the shorts and weak hands continue to crush this stock and investors grow tired of written claims not backed by a single approval. Perhaps those who talk are not talking loud enough. Yes I believe Remestemcel and Rexlostemcel work, or I wouldn’t still be here hundreds of thousands upside down. In every instance, after long silent instance, and trial after trial, the goals were set way too high, yet the results have all been very positive, better perhaps, than many other BLA applicants who have already sought and won approval. Yet the stock and the company continues to sink. MESO clearly does not have the means by itself, to move perhaps ANY of its excellent products. If the game is rigged, they had better figure out away around it. Still burning money like a drunken sailor. 4 drugs at the alleged finish line, but none physically able to cross it. I believe, yet and cannot leave at this point. I don’t think I am alone. If I bought 10 or 20,000 shares yesterday, I would feel pretty good a except for this companies history of talking a big game, but not being unable to finish. I have cashed this drug a couple times. It is time to get all this across the finish line! A little less talk and a lot more action please. I don’t believe I am alone in this sentiment. I don’t understand the hold up. I really don’t.
  • A
    Ariya
    Once again the circuses are back in towns, it all about sells on rumours and with no news, unlike last year’s the market is now factoring no partnership deal with Novartis and no FDA approval for SR-acute GVHD in children. The reversal will be swift if the traders got it all wrong. Christmas is just around the corner and only patience investors will be rewarded. GLTA investors 🍀🐢
  • P
    Praetorian1011
    Good days trade on the ASX today up 10%, perhaps us Aussies might be waking up on the significance of the latest CHF results..... Keep it going for us MESO holders!
  • W
    Will
    What a good announcement. Won’t raise the price of course until official confirmation but if we can submit a BLA for the heart product strap your seatbelts. Wasn’t expecting a bullish statement like that
  • S
    Steven
    More great announcements! I knew MESO would bounce back.
  • H
    Hipsterkicks
    “Biotech’s big haircut. Scrappy retail investors and big money managers alike can shake hands on one thing: losing money in biotech. It’s the worst-performing S&P sector of 2021. The SPDR Biotech ETF is down 22.3% YTD. The losses come after a meteoric few years for biotechs, but with its breakthrough into the mainstream, biotech has come down with a mean hangover. Historically, these big selloffs have preceded big gains, but some fund managers are down bad. Read more in The Wall Street Journal.” From my Stocktwits weekly email
  • S
    Seanpierre1
    a good start to the week. Even if it takes longer, in the end we stand there like Goldmarie.

    https://hotcopper.com.au/threads/ann-rexlemestrocel-greatest-benefit-in-diabetics-and-ischemics.6468455/
  • H
    Hipsterkicks
    Well we know why groupinvestor is silent today…he’s covering all of his short positions!
  • W
    Will
    What are the main thoughts on the CHF program?
    Listened to the last call this am, we all know the results, it seems SI wants to target elevated CRP patients which responded most for approval?

    In my experience this unlikely with the FDA.

    Any opinions on chances of approval?

    My dream secondary scenario (if no CHF approval is)
    1. Rem GVHD approval to bank roll other programs....
    2. ARDS parnership sealed.
    3. Likely new trial for CHF confirmatory...the only problem with this is the amount of time it would take!
    4. CLB new trial...
  • S
    Seanpierre1
    R&D Day 2021
    December 02, 2021 – Virtual
    14:00-19:00 CET | 13:00-18:00 GMT | 08:00-13:00 EST

    Download the agenda (PDF 0.2 MB)
    Download the presentation (PDF 32 MB)
    Read the media release

    Watch the webcast:
    Main Audience Event Link
    Audience Event Link China