MSB 0.00% $1.74 mesoblast limited

Here we go again. The well-worn, well-rehearsed Dolcevita...

  1. 149 Posts.
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    Here we go again. The well-worn, well-rehearsed Dolcevita practice of dissembling and obfuscation. I make clear points, and you bluster about something completely different. I will answer your points as clearly and succinctly as I'm able! So as to avoid further accusations of refusing to take your points:

    1. Lack of insults: you're right, I have backed off a bit, though not through lack of opportunity. Note to self: must try harder.

    2. Negative posters: there do seem to be more negatives than positives, I agree. I would idly speculate that this is because the overwhelming sentiment on MSB is negative rather than positive. I would further speculate that this is driven by:
    (a) A share price which is in the toilet (and judging from the events overnight, is shortly to disappear round the U-bend);
    (b) A failure by Celgene to consummate the relationship between the companies, and apparently giving them a free-kick in respect to the extension;
    (c) Apparent ambivalence from Teva.
    I stress the I am not taking a view on whether any of these issues are right or wrong; merely that they are driving sentiment.
    For what my personal view is worth, MSB will probably succeed in getting to market with one or more products. However, I believe that over the years, they have managed their cash badly, and scattered it around too many indications, rather than focussing on one or two, and preserving cash.

    3. FDA timing: I note that, yet again, you fail to lay out an alternate timeline based upon your own analysis.
    I acknowledge that my experience may well not be the last word. However, I know enough about the FDA to believe that "setting precedents" is not necessarily a good thing (hence my comments about stopping the clock earlier). With a first-in-class medicine, the FDA are more cautious - and with a first-in-class biological, they are even more cautious, because of the inherent manufacturing difficulties.
    Of course, none of these issues are insurmountable. However, if I were doing my planning in MSB, I would absolutely not be assuming that this will go through without questions. Meaning that the timing of an approval will likely be later, rather than sooner.

    4. MSB looking at a "higher level of treatment than pharmaceutical drugs":
    I don't understand what this means, and I suspect that you don't either.
    It is true to say that pharmaceuticals can affect different genotype so differently. So far as I'm aware (and I stand to be corrected with data), it is not different for stem cell-based products. In fact, arguably, it's even more complex for stem cell-based products because of course, product made from different cell donors, are, well, different. Perhaps unsurprisingly Dolcevita, stem cell product made from your bone marrow, will differ from that made from mine. Whilst the company will have developed potency assays in in vitro models, there's no reason to suppose (so far as I'm aware) that there will be any fewer "non-responders" in a population than with conventional pharmaceuticals.

    5. Phase 3 fast tracking: You suggest that this will occur if no side effects are observed (and I agree that, to date, in common with every other stem cell product in development, there are no significant adverse events). My understanding however, is that the truncation of the trial will occur, not on a safety read out, but on a signal for "overwhelming efficacy". This is a much higher hurdle than a simple lack of side effects. Please correct any misunderstanding on my part. As such, the potential for fast track (which I again stress, is different from priority review) is perhaps diminished.

    6. My misleading efforts:
    I have absolutely not set out to mislead. I have provided opinion based upon my experience, MSBs timelines, and, to repeat, the CEOs reticence at the AGM, as reported by you.
    In my opinion, readers are more likely to be misled by vague, hand-waving generalisations, and therefore by your approach, rather than mine.
    IMO, as you always like to say.

    7. Japanese approval:
    Why do you say I was surprised? When have I indicated surprise? Or is this an(other) assumption on your part.

    7. Data and timelines:
    It's how drug companies work.
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