Despite the kind of replies I have been presented with when going over to the MSB thread back in 2018, in addition to your references to my posts - either by directly mentioning my nick (although incorrectly spelling it) or by referring to some of my comments - I have no intention of making any "shut down commentary" and I'm not sure what makes you think that. I have mentioned numerous times that I take great pleasure in a discussion, even/especially if it leads to me being proven wrong. I genuinely enjoy reading up on this space. Perhaps because it is more exciting than taxation.
You keep going on about trial design, "comparing the incomparable", yet when I referenced one of the JCR TEMCELL trials and results (see below), you couldn't even be bothered checking even the basics
@Chacra you might appreciate the below):
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I'm actually comparing a study of adults vs a study of adults:That's thePhase 1/2trial (14 patients), conducted by JCR in Japan - which is the one I was referring to first -"Themedian age was 52 years(range 4–62 years). Thirteen patients were adults, while only one was a child."http://www.mesoblast.com/images/pdf/Japanese-Society-Hematology-July2013.pdfAnd thePhase 2/3trial (25 patients), also conducted by JCR in Japan"https://hotcopper.com.au/threads/msb-trading.4042474/page-56#post-36943849I was comparing apples with apples as you called it.
You then kept going on about "comparing sick patients with even sicker patients", which to a degree was a valid point, until a research paper prompted be to look further into the actual trial design:
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After more than a decade of clinical study involving 3 distinct advanced trials,40-42it appears that thawed allogeneic marrow-derived MSCs (remestemcel-L) administered IV may well meet the regulatory requirements for marketing approval in the United States for acute steroid refractory GVHD in children as pursued by Mesoblast Inc.43"
https://ashpublications.org/bloodadvances/article/4/9/1987/454869/Mesenchymal-stromal-cell-therapeutic-potency-isBtw, MSB even mentioned Jacques Galiepeau's paper in one of their ASX announcments:
http://investorsmedia.mesoblast.com/static-files/c0807204-3d05-4b03-adb9-d05066d8491d"involving 3 distinct trials"?
About a year earlier he also published the following (sorry, I have quoted it before but given your clinical trial agenda today, I feel it should be posted again PLUS I have highlighted a few things I consider important):
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In GvHD, it has been observed that children respond better to allogeneic MSCs than do adults overall (Kurtzberg et al., 2010) and treating patients early on is better than delaying therapy after onset acute GvHD (Ball et al., 2013). Gut and liver GvHD are more responsive than skin GvHD. In the absence of robust predictive biomarkers, these observations provide guidance in clinical trial design biased towards subject selection likely to be responders. These data likely informed an adaptive clinical trial design forNCT02336230where identical MSC product and dosing scheme between both studies was maintained but where the definition of response, age of inclusion, severity of disease and exclusion of skin-only GvHD, as well as a more aggressive start time for MSC transfusion were implemented []. The latter Mesoblast-sponsored study of marrow MSCs in pediatric GvHD completed recruitment in December 2017. In February 2018, it was announced by press release that the study had successfully met the primary endpoint of improved Day 28 Overall Response (OR) in steroid-refractory pediatric subjects with severe disease. Day 28 OR was 69% and was significantly improved (p=0.0003) compared to protocol-defined historical control rate of 45%. This outcome likely foreshadows the first FDA approved MSC product in the USA. In the absence of robust predictive biomarkers of response, the judicious use of clinical observation and subgroup analysis of responders and non-responders in early phase clinical trials may inform the rational selection of patients enrolled in advanced clinical trials so as to bias towards outcomes meeting primary clinical endpoints of success."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6434696/Let me get this straight, there is nothing wrong with that and remestemcel-L will save a lot of lifes without a doubt. I have also mentioned that in my recent HC post on the MSB thread, when most of the "DYOR" rats left what they thought to be a sinking MSB ship. There was no way the treatment wouldn't be approved. You say because the product is consistent, I say it is consistent enough, especially given the lack of an alternative in addition to the fact that there was strong clinical evidence in these subgroups that remestemcel-L works. Any safety concerns in my opinion were more of a "well, we might as well list it so that no one can say we didn't". The PMDA came to the same conclusion five years earlier, despite noting inconsistencies amongst the batches.
https://hotcopper.com.au/threads/ann-fda-advisory-committee-sets-review-date-for-remestemcel-l.5511840/page-576?post_id=46499393Your final answer to any discussion then seems to be your 3D bioreactor:
"anyway I think 3d is in the bag, something the loyal followers of CYP claimed didn’t exist. Lol" and "My view: The additional bone marrow harvest cost, is really nothing in the grand scheme of things. Then you add in 3D and our media. IMO".
Who said it doesn't exist?
I just find it amusing that you keep mentioning things along the lines of "as far as any manufacturing claim, they haven’t manufactured more than a few doses".
https://www.mesoblast.com/science/manufacturingCOGS cuts
The manufacturing expansion will also help Mesoblast reduce its cost of goods sold (COGS) according to Itescu
“We will be moving to three dimensional bioreactors to reduce labor costs and improved manufacturing efficiencies. And these innovations will significantly reduce in the future our cost of goods.”
This was echoed by spokeswoman Julie Meldrum, who told us the 3D bioreactors “will be used to further optimize the manufacturing processes to increase yield and lower the cost of goods of our off-the-shelf cellular medicines.”
https://bioprocessintl.com/bioprocess-insider/therapeutic-class/mesoblast-planning-capacity-hike-if-gvhd-candidate-is-effective-against-covid-19/The way I read it, that technology has not been implemented yet, making your statement (for which you seem to be claiming a victory point every time it comes up) nothing but a comparison of a technology that has only produced a few doses versus a a technology in which significant advances have been made and that will be applied to reduce in the future their COGS.
And about informing investors, why don't you start with the guys on your thread, e.g.
@mrkahn84, who had the following to say:
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So I predicted that CYP will head up and is a good a small bet on the side if you believe strongly in MSB. After all they using our patents and would have to pay us royalties in the future if they commercialise their product in Australia. [...]"
https://hotcopper.com.au/threads/msb-trading-aug-2020-on.5542955/page-2176?post_id=46588891Given that these statements are constantly being made on the MSB thread without any evidence/sources, not causing any questions or anything. It is all perfectly accepted because it is the MSB thread and somehow different rules seem to apply there. If someone however makes a claim on the CYP thread, even if it is only a matter of misinterpretation on the reader side, sure enough a "knight in shining white armour" comes to our thread for the rescue of these innocent investor souls. I know, you kept telling us for years that you have tried to teach us, warned us etc. yet we seem to be resilient wanting to rely on our own research instead of being shown "the light". I will keep at it: doing my own research and evaluate my investment accordingly and on a regular basis.
I apologise if I have offended anyone. That wasn't my intention. Please feel free to report this post if found to be too offensive.
(20min delay)