@Lopez Sector really does have a fanciful idea of his own capabilities . This is the poster who thinks that our CLBP treatment will be low margin, when it requires just a single injection of just 6m cells ! You could not make up the stupidity of such a comment . He completely ignores the FACT that our cells are currently used in commercial practice for other indications with much higher volumes….and that JCR pays us a mid 20’s percent royalties and still makes a handsome margin on Temcell…which is now the first line treatment for treatment of severe grade steroid refractory active GVHD for both adults and children in Japan.
Temcell is administered with ….four doses per first treatment …sold to hospitals in bags of 72m cells ….and further cells may be used for non responders.
[Dosage and administration or method of use]The usual dosage of Temcell is 2 × 106 human mesenchymal stem cells/kg body weight administered as a slow intravenous infusion at a controlled rate of 4 mL/min. One bag of Temcell should be diluted with 18 mL of physiological saline. Temcell should be administered twice weekly for 4 weeks with infusions at least 3 days apart. The dose of 2 × 106 human mesenchymal stem cells/kg can futher be given once weekly for additional 4 weeks, depending on the degree of symptoms.
https://www.pmda.go.jp/files/000215658.pdfThen we have this idea that Mesoblast is inept because it does not currently utilise large scale 3D bioreactors .
As part of the normal regulatory process for CMC audit requires at least 10 separate manufacturing runs . Can you imagine the cost of doing that for Ryoncil to provide cells for an orphan indication for 200 kids a year ? Does he not understand that using 3D bioreactors actually hinder the FDA from being able to monitor the varies stages of cell morphology, PND’s and potency. It also changes the clinical results for many technical reasons I can explain to him if he requires further educating.
He is obviously not conversant with FDA requirements for real time monitoring and the need for off line analysis of continuous or perfusion culture batch processes for in-process quality control .
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8340809/What a joker. So let me explain again Sector. Mesoblast currently uses unit packaging of 25 million cells per vial (we have a more upgraded process that has done away with bags)…but that can obviously vary volume per vial if appropriate. In fact the whole reason why Mesoblast chose sr aGVHD as their first indication is establish the pricing as an orphan indication …its called establishing high reference pricing of the basis of cost of cells per vial. I believe this is the primary reason why the Company did not launch its therapies in Canada and New Zealand when it had approval to do so years ago…because it would have set a precedent of much lower reference pricing .
Then on the subject of IPSC….its a bit rich comparing CYP with MSB. From memory I am not sure they even treated any Grade D patients with the highest mortality.…out of a trial with approx 15 patients for Cymerus ? . We have treated as many as 1000 patients (including our EAP and Temcell) and there is almost 20 years? evidence of MSCS used in this indication. As to cancer risk , I am aware of the measures taken in their last clinical trial to negate risk of tumorgenicity but if you think the FDA are going to allow approval without long term safety data being established , I think he should be carted off to the funny farm. Theoretically there is very reason to be excited about some of the advantages of ISPC but the reality is they will have to be a long body of clinical trial evidence before they are approved. Perhaps Sector could inform us of the age, sex, race , etc of his universal donor? He must be aware of the meta data for many indications showing advantages between different genotypes of donor. Unsurprisingly, one of the fathers of ISPC, Shinya Yamanaka, is well aware of issues, such as hepatic differentiation and is now pursuing a far more refined approach to using ISPCs.
Come on Sector …simple question…what is the genotype/phenotype of your universal donor ? Do you honestly believe that one cell donor is optimal therapy for all patients . I suggest you read Kilpinen et al., 2017 and Guhr et al 2018…As Popp et al 2018 has also referenced …your oversimplification of complex subjects just exposes your naivety. I would not mind so much as your points form the basis for a sensible discussion but your persistent trolling and ridiculing of so many posters is totally disrespectful …please grow up and stop lowering the tone of debate into a kindergarten brawl.
”ISPC culture and differentiation are a multi step process, small variations at each step can inevitably accumulate, generating significantly different outcomes “
https://www.pnas.org/content/109/31/12538https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6994963/ In the meantime Silviu believes our cost of goods percentage relative to sales on volume production should be lower than 10% for many indications as a result of recent breakthroughs using exiting methodologies …which I believe will improve our productivity fivefold. Once we achieve OTAT acceptance of our potency assays we are pretty much good to go …the only thing Sector need worry about is achieving statistical significance when Cynata’s cells are put head to head in a phase 3 US clinical trial against Ryoncil in many years time ! As I believe the cells have virtually identical surface receptors, I think that will prove very interesting . If Sector would like to prove otherwise please show how you surface receptors including TLRs…vary from our cells? We are all waiting ……
Meanwhile, I believe the next nine months promises to be transformative for Mesoblast. Assuming a regulatory filing of a BLA for Ryoncil and the clarification of our regulatory pathway in CHF with the potential for accelerated approval , combined with a further ARDS trial ? Crohns and UC results ? and partnering deals …make for an interesting time. …at a time when our share price languishes at multi year lows as the whole sector (pun intended) is imploding . What an opportunity. I picked up a lots more shares yesterday but Mesoblast is not immune to the short term tempest in the biotechs . I look forward to the recovery when it comes…and surely it will come ! OP
Please do not rely on the facts or opinions given in the above post . Do your own research and seek independent investment advice. Biotech shares are extremely speculative and volatile especially pre FDA authorisations.
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