@SectorSInce you make your points in a sensible way , I will ignore the barbs and try to focus on some of the basics ...but i have not got time to do back and forths with you ...so consider this a one off reply.
Your knowledge of the JCR situation, if I recall, was encapsulated in a one short page Japanese translation unearthed by another resourceful poster. It is true that I had not seen,nor translated that page .... it appears you expected the IR department of Mesoblast to correct public guidance for another listed company over in Japan because they had a problem with a batch of cells while upgrading production capacity. Well it never seemed to bother the shareholders or share price of JCR ...but you certainly wanted to read a lot more into it . What a surprise.
JCR has now confirmed it is ramping up capacity to deal with substantial growth in demand. ..So I can live with your protestations.
Let me help you with a few realities of your own.
An FBS free serum for Mesoblast ? .....you need to read up a bit :
https://www.freepatentsonline.com/y2020/0040303.htmlThis is just one of many patents......successfully filed by Mesoblast that provides a xeno free medium when required ...which I believe is ready, subject to approval, for use .
Then regarding “our myth” of 3D manufacturing capability ...have you read the obvious from our production partner ? You might want to get in to touch with them about their mythical claims on their website.
https://pharma.lonza.com/technologies-products/3d-bioreactor-technologyBut have you asked yourself a few simple questions. Will the FDA want to release Mesoblast from 2D manufacturing protocols which currently allow continuous staged control over batch production.. until they have formally signed off on all the CMC ...especially the critical quality attributes, approved efficacy biomarkers and other required checks and regulatory balances ? A new process will require a new application which can be progressed faster post approval . Furthermore, why would Mesoblast want to use 3D bioreactor technology when they were only meant to be producing small quantities for sr GVHD ? Do you honestly think that paying $7m for proprietary media to be used in a single manufacturing run of a large stirred bioreactor is necessary..when a more straightforward cost effective method is available with a regulatory dataset.
Furthermore, in my experience of technology. Scaling up is an iterative process. Continuous manufacturing normally brings substantial improvements in yields as seen in technology with Moore’s law etc. If Cynata actually manages to get a product to market in five years time in the US, Mesoblast will probably by then have single digit COS ...and that I believe , represents less than the license payments you have to make,to even use the IP ?... which does not belong to you.
Lastly, have you compared the final observable phenotype of your cells compared to ours ? Let me know your conclusions. I am interested as will some IP specialists I know .
Merry Christmas
....let the datasets from the phase 3 trials do the talking... because seriously, there is so much that neither of us know right now. OP
P.S. We just blew the hinges off the door in the treatment of Grade 2B CHF ! Apparently we achieved very consistent results across ischemic and non ischemic patients in reduction of strokes and heart attacks ...suggesting excellent reproducibility and potency with no safety issues . Must be doing something right . Must be luck .
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