@LearningEachDay . The stench of manipulation is all over this share but it will be pretty irrelevant if we have a positive OTAT meeting. The numbers produced by Shortman show a sustained shorting attack on Meso
blast over the last week or so , coinciding with some bizarre rumours the AFR were seeing to “clarify” which were then formally rebutted by the Company as totally inaccurate.
I continue to spend several hours a day pouring over research so I try not to allow myself to be distracted by the serial downrampers….but while I am here I might as well put paid to the ridiculous comparisons with Cynata over fiscal terms for use of IP. The royalty payments which Mesoblast agreed to pay Osiris, average mid
single digits on the
first billion of sales of Remestemcel only (conditions apply) ..and are
capped at a maximum level of
10 % above the first $1bn . COMPARE that to the
30 % that Cynata would apparently have to pay for their volume related IP. I do appreciate that Cynata has a very impressive partner with Fujifilm and CDI. It does not have to fund its R&D which is very useful for a small cap….but it is not in complete control of either manufacturing or the amount spent on research or the speed of development . Mesoblast on the other hand normally stipulates a cost plus margin arrangement to supply licencees and has the option to purchase manufacturing GMP facilities from Lonza when it so wishes. As Silviu has already talked about bringing down Cost of goods sold down to 10% of sale price with already identified improvements , Cynata would be priced out.…...especially when its likely US regulatory pathway might be about four to five years away ? Has our resident troll ever wondered what would happen to Fujifilm’s appetite to spend large amounts developing new allogenic therapeutics if they signed a contract manufacturing deal with the market leader in allogenic therapies … or took them over ? Then what would happen to CYP ? The largest component costs in producing MSCs might surprise you, The growth media used, such as FBSO and not necessarily the cost of the cells themselves are extremely important factors MSB are moving to animal free growth serum shortly and using new methods such as long release ascorbic acids to reduce anti oxidative stress during processing. I notice that Cynata has only just been awarded a patent for its own animal free media …several years after Mesoblast registered its own proprietary animal free solution,
I could also point out that Mesoblast also has patents granted for using pluripotent cells. Another point that is totally missed by our resident troll is that Rexlemestrocel would pays
no such royalty to Osiris and is significantly superior for use in our blockbuster therapies for CHF and CLBP. If there were exclusivity clauses for Remestemcel, or minimum annual performance guarantees he might have a point …but no sign of those ! I would also point out that mesoangioblasts as a “feed stock” cultivated with FGF2 using DMSO in a 5% oxygen environment might be interpreted by many skilled in the art as sharing much in common with our own stromal cells.. but I will leave that to the patent lawyers and your imagination. Interesting how Cynata has employed Dr Kelly as COO having previously worked at Mesoblast . I also appreciate there are advantages to scaled manufacture from cloning… but I am sure Silviu realised it might take years of safety data to persuade the FDA that clonally derived cells are safe…and I don’t think he wanted to spend the next 5 years reworking historic data just before a potential approval….. when he can simply apply to the FDA to modify CMC protocols
post approval on much shorter timescales. We are told CYP has done a Phase 1/2 trial …but this involved only 15 patients…..who were all white and none suffered from the most severe Grade 4 GVHD on enrolment . Would anyone like to tell us whether the “universal donor cell “ used by Cynata is from a man or a woman (female to male has more complications ) ? What is there background, age and genetic profile ? If you do not know why i am asking you should not be investing . Mesoblast also achieved higher efficacy results in ~GVHD001 with its subset of white patients compared to non white and I believe our trial investigator used more stringent interpretation of trial protocols to censure data. I wonder if Cynata is claiming to have optimised dosing now that they have used a stronger dose of their iPS cells on a a grand total of 7 patients ? Well it was an encouraging start….looong way to go !
So much now rests on this OTAT meeting. Mesoblast infers it is comfortable with the likely new potency assays being proposed … they should know by now… having spent the summer months constructively liaising with the FDA and then undertaking production tests to prove they can meet these new standards. The biomarkers ST2 and Reg3a, form a “liquid biopsy” showing endothelial damage emanating from the gut crypt, These are used by the MAGIC Consortium to undertake retrospective grading or comparability studies of patient data. This is a perfectly reasonable alternative to a placebo controls which are rightly considered unethical, for this particular indication for children as there is no existing standard of care. Experts in the field of GVHD know MAP scoring developed by MAGIC has been back tested on a huge worldwide patient database ..and is widely considered the gold standard . The peer reviewed studies of the Ann Arbor Algorithm devised by MAGIC shows incredible accuracy as a prognostic indicator of responders and non responders of srGVHD, even in the very early stages before clinical symptoms appear. The inadequacies of current grading methodologies for GVHD, like Glucksberg scoring ,resulted in a massive net reclassification percentage of disease severity when ST2 biomarkers were applied to examine previous reported patient grading scores .The criticism of the MAGIC consortium handed out by an FDA member at the ODAC hearing just about sums up how ludicrous the FDA position was. I would rate the expertise of Dr Joanne Kurtzberg & Prof John Levene in treating srGVHD ,over Steve Bauer of the FDA any day of the week. ..hopefully they realise from the data supplied to them that they have cocked up big time in issuing a CRL to Mesoblast.. Just watch what happens to investor sentiment in the most likely scenario where Novartis confirm shortly their enthusiasm to partner up with Mesoblast ! Good luck .
VIDEO Please do not rely on the accuracy of any fact or opinion given in the above post when making an investment decision .
wondering why you were $10, 10 years ago and why your CMCs are still being worked out after nearly 18 years....what's another US$10m a Q
(20min delay)