MSB 2.73% $2.26 mesoblast limited

autologous v allogeneic, page-43

  1. 149 Posts.
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    Really putting the hours in this weekend, Dolce! But I suppose if you're a shameless and relentless ramper, it goes with the territory.

    1. You accuse me of shorting. I'm not. I wouldn't know how. And you have no way of knowing whether I am or not either.

    2. I have explained, repeatedly, why I post on MSB and nothing else. In fact, I've done it within the last couple of weeks, but I guess that's your selective reading and shaky memory again. Post # 16341151 if you'd like to track it down. Actually, my 100th post, so a nice little milestone there.

    3. So, no data to substantiate your "Fact" that the thread is dominated by traders. No surprise there. As ever, you are accusation-heavy and data-lite. Also, see (1) above.

    4. I assume that the "unsubstantiated claims" troubling you in my last post relate to the people who seem to like my posts? As ever with you Dolce, it's not terribly clear. Assuming that it is, well you're correct, I can't substantiate it, because, honestly, I don't (and can't) really know the mind of the folks who post here. I admire your ability to understand, not just your own mind, but to divine the thoughts and intentions of a myriad LT holders, for whom you seem to be claiming to speak!
    For the record, I'm not targeting any holders, weak or strong, whatever that means. If I'm targeting anything at all, it's hubris and bullshit.

    5. FDA guidance document: so you're saying that MSB do their thing, the FDA write it up into a guidance document, so that MSB... can do their thing? Retrospective guidance?
    What part of "guidance" don't you understand?
    The FDA have been writing guidance documents on stem cell therapies for years. I know, because I've read most of them (oops! Unsubstantiated Claim alert!), and I know people who've helped write them (oops! Unsubst... actually, let's just call them UCA for the sake of brevity). In 100% of cases, the guidance preceded the action, as is typically the case in the real world.
    The extent of poverty of your understanding of the regulatory process is matched only by the magnitude of bogus authority with which you make your pronouncements. Poor Dolce - you want so much for people to think you're clever.

    6. Your accusation about the manufacturing furphy, and your further uninformed ranting about manufacturing:
    Further evidence, were it needed, that you simply don't know what you're talking about.
    Let me explain why donor variability is an issue. An individual donor's DNA is absolutely an issue, inasmuch as it determines the specific mix of biological factors which that donor's cells will produce. Now the FDA want to know that, notwithstanding these differences, the clinical effect on patients will be identical to that delivered by cells from other donors. It's actually nothing to do with safety (or at least, relatively little to do with safety), but to do with efficacy.
    So your comment about the "only issue" being about whether stem cells stimulate those of the recipient is typically simplistic. Not only do the cells have to stimulate those of the recipient, they have to stimulate them in exactly the same way as cells from the previous batch (and/or donor) and the next batch (and/or donor).
    And because this is a biological system, the minutiae of the manufacturing process is that much more critical. Incubate for a little too long, add half a gram too much of a particular nutrient, get the air mixture a little bit out - and you have a different cell.
    A conventional pharmaceutical doesn't have these problems; since it's not "alive", there re no donor issues, and manufacturing is essentially just bucket chemistry. Exacting bucket chemistry, but bucket chemistry nonetheless.
    As I said - I imagine that MSB has addressed these issues, but my opinion is that the review process is likely to be slower than faster because of it.
    But you think that there's a possibility of sales in 2017. So why don't you explain your rationale, and tell me why you think I'm wrong? Though I ask the question again, more in hope than expectation.

    You know why I don't post on capital market issues and related areas? Because I stick to posting about stuff I do know something about. It's a philosophy that might work for you. If nothing else, it would reduce the volume of your output by about 98.7%.

    7. Your 3 & 4 and clinical trials generally.
    Firstly, bit of a little fib from you there Dolce. Haven't ever said that trials can't be shortened, so that's you doing a(nother) little pirouette there, not me.
    Yes, you're right, MSB and the FDA have looked at their data, and reckon that it's worth having a crack for overwhelming efficacy. Good for them, and I wish them luck. I still think it's a high hurdle though, and I guess we'll have to agree to differ. If Phase 2 results always predicted Phase 3 outcomes, then no drugs would ever fail Phase 3. Yet of course, they do, with depressing and expensive regularity, for the industry.
    It's worth noting of course that the study which has potential to be shortened has to be supplemented by a second study, which, looking at the AGM presentation, seems to report in the second half of 2018, so perhaps it's a moot point what effect the primary trial shortening will have on the submission date anyway.

    8. Scale up of manufacturing
    If your timelines for launch are accurate, you'd better hope that MSB does have appropriate scale up.

    9. Your reference to my 7, 8, 9
    Your supposed "Fact" about my outdated and inapplicable models.
    I note that you have, once again, failed to counter my model with a more up to date and applicable one of your own. Does it ever occur to you that it would be easier either to: (a) provide actual specific answers, instead of a blizzard of indignant, hand-waving generalisations, or (b) say something like "Do you know Fruitbat, you made a good point there. Thanks. I learned something.", or "I don't know", or "Sorry about the last several hundred posts, I was just spouting my usual bollocks."?

    I'm not a trader. How can I be? I don't hold. So my comments are not those of a trader. In any case, I further note that you have, yet again, failed to explain why being a trader is so heinous.

    At least there is one thing upon which we agree: people should never act upon what is said in a chat room. After all, there might be people in there anxious to spruik the stock for their own personal gain, by using bogus "facts" and a rudimentary understanding of the biologicals development process buffed up by hubris to appear authoritative.
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