MSB 3.24% $1.79 mesoblast limited

1. My "cheer squad" as you like to call it. What I find...

  1. 149 Posts.
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    1. My "cheer squad" as you like to call it.
    What I find interesting are the wide range of people who appear to like some of the things that I write. There are people that you would perhaps describe as the "usual suspects". However, there are people who post things which, frankly run counter to my narrative. In any case, I write what I write, and if some folks like it, well that's good. If they don't, I won't lose sleep.

    2. The "Fact" that traders dominate the MSB thread.
    Just as a matter of interest, how did you come by your shares? Did you trade something of value in exchange for them? Like money? Perhaps you sold some other shares to generate the cash to pay for them? And at some point in the future, will you not trade your shares with someone else, in exchange for some money?
    Or did your MSB shares spontaneously condense from the ether? Perhaps you found them in a reed basket, floating down a river. And when the time comes when they are valuable, you'll use them to light a barbecue.
    Yes, traders dominate the thread because everyone who owns shares on the thread has bought them and intends to sell them. Of course, you're using "trader" as a perjorative, as if it were somehow illegal, unethical or immoral to buy and sell shares more frequently than you would rather they do.
    But adopting your definition of "trader": please substantiate this "fact". I believe that you have no evidence to support it.

    3. Stem cell therapies "higher up the treatment chain than pharmaceutical drugs on which FDA safety systems have been based".
    I've been back to the AGM commentary;
    I've thought.
    I'm none the wiser about what you're on about.
    The FDA doesn't care where "on the treatment chain" a drug is, whatever that means. They want a company to show safety and efficacy, and the number of patients required to do that to their satisfaction is determined by pre-clinical data, early phase studies, whether it's an active or placebo control,and statistical analysis.
    However, please feel free to correct me by posting a link to the FDA guidance document, which discusses the use of stem cells in the treatment chain, and in some way, reduces the burden of proof placed on the manufacturer.

    4. I "finally admit" that the FDAs response is an endorsement about the safety of MSBs cells:
    Aah, another of Dolce's greatest hits. Reading your posts is like listening to Gold FM. The subtle twisting of ones words, and highly selective reading... hang on, let me just get over the nostalgia....
    ...
    Ok, we're back live, and ready to return to the prosaic world of the facts.
    I did say MSBs cells were safe. I've always said they were safe. What I've also said is that EVERYONE's stem cells are safe! So, little bit selective there, Dolce.
    I also said that, to my understanding, the Phase 3 will be shortened, not on a safety read out, but on an efficacy one. I've just gone back to the AGM slide, on the subject, and I think that I'm correct. So, these things can be as safe as fresh, clean water, but if there is no signal for overwhelming efficacy, then the trial continues to the original end.

    "Long clinical trials are to exclude problems as unanticipated complications arise from different patients response".
    Look, I don't know where to begin to decipher this gibberish. Clinical trial design is essentially a statistical exercise. Phase 3 studies are principally powered to detect efficacy signals. What is happening with the MSB CHF study is that the patient population is being enriched with likely better responders. This will, if things go to plan, result in an overwhelming efficacy response in that group. That will result in the study being truncated.
    So the "long" study is not being shortened to "exclude unanticipated complications" at all.
    You've got it all round your neck again Dolce.

    5. Your key question: why do I think efficacy will be a problem?
    I haven't said that it will. I've said - and I repeat - that "overwhelming efficacy" seems to me to be a very high hurdle.
    Leaving aside whether Macbank's analysis was correct or flawed, it is correct to say that MSBs products have yet to successfully complete a Phase 3 program that will demonstrate unequivocally that they work in CHF - even just enough! Let alone with "overwhelming efficacy".
    In fact, no other stem cell products have shown "overwhelming efficacy" in CHF. And I'm unaware of any ACE inhibitors, beta-blockers, diuretics or anything else that have shown "overwhelming efficacy". So, I'm cautious.

    Not that you'll believe me, but I really, really hope that it does. It would be great for MSB, for regenerative medicine, and for the beleaguered Aussie biotech sector. But I'm not going to try to fool people into thinking its a slam dunk, as you seem wont to do.

    6. Manufacturing:
    I've explained this all before, but you must have forgotten. Perhaps you could start filing my posts for easy reference?
    The problem with stem cells, is the same problem as for monoclonal antibodies, and informs the FDAs issues with generic biologicals manufacture. Unlike a conventional drug, the clinical effect is uniquely allied to the manufacturing process. Change the process and you get a different outcome (hence the problem with generic monoclonals). With stem cells, the problems are compounded by donor variability. With a monoclonal, you can use an immortal clone to manufacture product. Not possible for stem cells. So, you have to keep going back to the well donors. But every donor is different! So how do you reliably, and repeatedly generate the same product - and crucially, the same product that you used in your clinical trials - if your source material is different? Well, you can't. So, you have to rely upon either (1) clinically validating every batch, or (2) developing bulletproof potency assays. And they're a problem, because nobody knows which of the thousands of molecules that a stem cell produces, are having the clinical effect.
    That's what I mean when I say "manufacturing problems".
    I'm sure that MSB will have resolved these issues. But the FDA will be poking around extremely carefully, for the reasons articulated above.
    Result: slower, rather than faster approval.

    7. Misrepresent statements and shift ground.
    Pot. Kettle. Black.

    8. My timelines are based upon an outdated and inapplicable model. "Fact"
    You may be right, and I'm happy to be corrected. However, you have posted no supporting evidence, or timelines, or indeed, anything of substance, to support your position.
    I'm always keen to learn, so please feel free to post links to the FDA guidance documents, precedence, or anything else which provides data to support your views over mine.
    Only don't post more spluttering nonsense, because it doesn't help anyone.

    9. LT holders
    I too wish them good luck. I hope MSB does well. Of course, they may have to trade, in order to realise the fruits of their patience.
 
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